Stimulator, Muscle, Powered
A Powered Muscle Stimulator is an electrical therapy device used in Physical Medicine to deliver electrical current to skeletal muscles via surface electrodes, causing muscle contractions for purposes such as preventing muscle atrophy, re-educating muscle function, improving circulation, and managing chronic pain. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is IPF, regulated under 21 CFR 890.5850, within the Physical Medicine medical specialty. This device is eligible for third party review, meaning the 510(k) submission may be reviewed by an FDA-accredited third party organization.
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Basic Information
- Product Code
- IPF
- Device Class
- FDA class 2
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 548 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253542 | Apollo Quattro (APQ-10M) | Jun 08, 2026 | Substantially Equivalent | Weero Co., Ltd. |
| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP) | Jun 02, 2026 | Substantially Equivalent | Mohammadali Nezakati |
| K260142 | StimelMD (SSMD) system | May 27, 2026 | Substantially Equivalent | Motion Informatics ltd. |
| K251083 | Compact II | Sep 12, 2025 | Substantially Equivalent | Enraf-Nonius, B.V. |
| K241433 | EVE Synergy (EVE-20M) | Jun 04, 2025 | Substantially Equivalent | Weero Co., Ltd. |
| K241488 | TrainFES Advance | Feb 05, 2025 | Substantially Equivalent | Trainfes |
| K240348 | Quantum Mitohormesis (QMT) (M2101) | Dec 19, 2024 | Substantially Equivalent | Quantumtx Pte. , Ltd. |
| K240992 | eMVFit (MVF-10M) | Oct 10, 2024 | Substantially Equivalent | Weero Co., Ltd. |
| K240234 | BTL-899MS | Aug 17, 2024 | Substantially Equivalent | BTL Industries, Inc. |
| K233098 | MYOTouch Muscle Stimulator | Aug 02, 2024 | Substantially Equivalent | Sunmed, LLC |
| K232786 | Stimulation System (PA series, PR series, S series and Q series) | May 16, 2024 | Substantially Equivalent | Edan Instruments, Inc. |
| K233926 | accufit | Mar 21, 2024 | Substantially Equivalent | Mettler Electronics Corporation |
| K233485 | M-Wave | Jan 26, 2024 | Substantially Equivalent | Zynex Medical, Inc. |
| K232937 | BTL-899M | Dec 26, 2023 | Substantially Equivalent | BTL Industries, Inc. |
| K230701 | Stim2Go | Nov 24, 2023 | Substantially Equivalent | PAJUNK GmbH Medizintechnologie |
| K231440 | Combo Electrotherapy Device | Nov 03, 2023 | Substantially Equivalent | Shenzhen Roundwhale Technology Co. , Ltd. |
| K223027 | NeuroTrigger Basic (NTB) | Oct 10, 2023 | Substantially Equivalent | Neurotrigger |
| K223802 | accufit | Oct 06, 2023 | Substantially Equivalent | Mettler Electronics Corporation |
| K221274 | StarFormer, TightWave | Sep 29, 2023 | Substantially Equivalent | Fotona D.O.O. |
| K230167 | BACK 4 | Sep 14, 2023 | Substantially Equivalent | Swims America Corp |
| K232334 | DEKA SIMON | Sep 01, 2023 | Substantially Equivalent | El.En S.P.A. |
| K213655 | HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) | Jan 17, 2023 | Substantially Equivalent | Hilltek, LLC |
| K222201 | Biological Feedback and Stimulation System | Oct 21, 2022 | Substantially Equivalent | Medlander Medical Technology, Inc. |
| K221958 | Flex-MI | Oct 21, 2022 | Substantially Equivalent | Emsi, Inc. |
| K220994 | Shoulder PacemakerTM | Oct 14, 2022 | Substantially Equivalent | Ncs Lab Srl |
| K213197 | MyOnyx System | Jun 17, 2022 | Substantially Equivalent | Thought Technology , Ltd. |
| K220738 | Motive Knee Wrap | May 12, 2022 | Substantially Equivalent | Cymedica Orthopedics, Inc. |
| K220327 | geko W-3 | Mar 04, 2022 | Substantially Equivalent | Firstkind Limited |
| K213043 | Levator Elite (Model LE9011) | Feb 25, 2022 | Substantially Equivalent | Shenzhen Dongdixin Technology Co., Ltd. |
| K212832 | TimeWaver Frequency | Dec 14, 2021 | Substantially Equivalent | Timewaver Production GmbH |
| K212762 | geko W-2 | Nov 29, 2021 | Substantially Equivalent | Firstkind Limited |
| K192746 | MyoWorx TM20 | Oct 19, 2021 | Substantially Equivalent | Myoworx, Inc. |
| K210002 | STELLA BIO | Oct 01, 2021 | Substantially Equivalent | Egzotech Sp. Z O. O. |
| K210674 | Shoulder Pacemaker | Aug 24, 2021 | Substantially Equivalent | Ncs Lab Srl |
| K210938 | PowerDot PD-01MT2 Muscle Stimulator | Jul 30, 2021 | Substantially Equivalent | Smartmissimo Technologies Pte, Ltd. |
| K211094 | Nerve and Muscle Stimulator | Jul 08, 2021 | Substantially Equivalent | Shenzhen Xft Medical Limited |
| K210604 | Intellihab System | Jun 03, 2021 | Substantially Equivalent | Cymedica Orthopedics, Inc. |
| K210979 | Prelivia | May 13, 2021 | Substantially Equivalent | Rehabtronics, Inc. |
| K210572 | Neurodyn V2.0, Neurodyn Aussie V2.0 | May 11, 2021 | Substantially Equivalent | Ibramed Equipamentos Medicos |
| K202031 | Talent-Pro Electromagnetic Stimulator | May 06, 2021 | Substantially Equivalent | Remed Co., Ltd. |
| K203710 | Storz Medical MAGNETOLITH Muscle Stimulator | May 03, 2021 | Substantially Equivalent | Storz Medical AG |
| K201285 | InMode Evolve System with the Tone Applicator | Mar 05, 2021 | Substantially Equivalent | InMode , Ltd. |
| K210269 | PowerDot PD-01MT2 Muscle Stimulator | Feb 23, 2021 | Substantially Equivalent | Smartmissimo Technologies Pte, Ltd. |
| K203488 | emField | Feb 19, 2021 | Substantially Equivalent | Zimmer Medizinsysteme GmbH |
| K202648 | Biofeedback Nerve and Muscle Stimulator | Dec 08, 2020 | Substantially Equivalent | Shenzhen Konmed Technology Co., Ltd. |
| K202079 | Physiq | Nov 25, 2020 | Substantially Equivalent | El.En Electronic Engineering Spa |
| K202490 | Avid CT2 | Nov 16, 2020 | Substantially Equivalent | Vision Quest Industries Inc./Dba VQ Orthocare |
| K200088 | g.Estim FES | Oct 29, 2020 | Substantially Equivalent | G.Tec Medical Engineering GmbH |
| K201290 | Medline DeNovo 4Pro Electrical Stimulation Device | Sep 21, 2020 | Substantially Equivalent | Medline Industries, Inc. |
| K201958 | ETD Family of Electrotherapy Devices | Aug 04, 2020 | Substantially Equivalent | Therasigma, LLC |
| K193275 | Nerve and Muscle Stimulator | Apr 11, 2020 | Substantially Equivalent | Shenzhen Xft Medical Limited |
| K193045 | geko W-2 | Jan 18, 2020 | Substantially Equivalent | Firstkind Limited |
| K183074 | TENS and EMS Stimulator, TENS Stimulator | Jan 11, 2020 | Substantially Equivalent | Astek Technology , Ltd. |
| K192733 | RelieforMe TENS/EMS Device Model UPK-GE01 | Dec 23, 2019 | Substantially Equivalent | Umeheal , Ltd. |
| K192249 | InMode System with Tone Applicator | Dec 17, 2019 | Substantially Equivalent | InMode , Ltd. |
| K191113 | geko T-2 and geko T-3 Neuromuscular Stimulators | Sep 18, 2019 | Substantially Equivalent | Firstkind Limited |
| K182163 | Shear Stress Therapeutics SST 3000 | Jul 09, 2019 | Substantially Equivalent | Shear Stress Therapeutics, LLC |
| K181759 | PowerDot PD-01MT | Nov 09, 2018 | Substantially Equivalent | Smartmissimo Technologies Pte, Ltd. |
| K181688 | R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator | Sep 07, 2018 | Substantially Equivalent | Shenzhen Roundwhale Technology Co. , Ltd. |
| K181059 | geko T-3 Neuromuscular Stimulator | May 23, 2018 | Substantially Equivalent | Firstkind Limited |
| K172381 | Digitimer DS7AP Constant Current Stimulator | Mar 06, 2018 | Substantially Equivalent | Digitimer , Ltd. |
| K180082 | geko T-2 and geko Plus R-2 | Feb 11, 2018 | Substantially Equivalent | Firstkind, Ltd. |
| K171978 | Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 | Oct 02, 2017 | Substantially Equivalent | Shenzhen Dongdixin Technology Co., Ltd. |
| K171071 | StimSox(TM) System | Aug 09, 2017 | Substantially Equivalent | Stimmed, LLC |
| K171387 | EMS100 Tri-Wave Combination Stimulator | May 31, 2017 | Substantially Equivalent | Elite Medical Supply of New York, LLC |
| K163125 | geko T-2 and geko Plus R-2 Neuromuscular Stimulators | Apr 10, 2017 | Substantially Equivalent | Firstkind Limited |
| K162987 | FA100 SCCD (Sequential Continuous Contraction Device) | Feb 14, 2017 | Substantially Equivalent | Flowaid Medical Technologies, Corp |
| K160614 | Xcite Clinical Station | Dec 16, 2016 | Substantially Equivalent | Restorative Therapies, Inc. |
| K163067 | CyMedica e-vive System; CY-1000 | Dec 01, 2016 | Substantially Equivalent | Cymedica Orthopedics, Inc. |
| K160992 | HPM-6000 | Oct 21, 2016 | Substantially Equivalent | BTL Industries, Inc. |
| K151922 | StimSox(TM) System | Apr 15, 2016 | Substantially Equivalent | Stimmed, LLC |
| K153696 | Chattanooga Revolution Wireless | Apr 14, 2016 | Substantially Equivalent | Djo, LLC |
| K160299 | geko(TM) Plus R-2 Neuromuscular Stimulator | Apr 08, 2016 | Substantially Equivalent | Firstkind Limited |
| K153224 | VitalStim(R) Plus Electrotherapy System | Feb 17, 2016 | Substantially Equivalent | Djo, LLC |
| K152677 | geko T-2 Neuromuscular Stimulator | Oct 23, 2015 | Substantially Equivalent | Firstkind Limited |
| K150742 | Muscle Stimulation System 110 | Jul 23, 2015 | Substantially Equivalent | Niveus Medical, Inc. |
| K150413 | QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator | Apr 02, 2015 | Substantially Equivalent | Cymedica Orthopedics, Inc. |
| K140467 | FLEX-MT + | Oct 07, 2014 | Substantially Equivalent | Emsi |
| K133638 | GEKO | Aug 21, 2014 | Substantially Equivalent | Firstkind Limited |
| K131917 | NEURODYN COMPACT, NEURODYN II | Apr 29, 2014 | Substantially Equivalent | Ibramed Equipamentos Medicos |
| K132284 | VECTRA NEO CLINICAL THERAPY SYSTEM | Apr 10, 2014 | Substantially Equivalent | Djo, LLC |
| K130691 | ELECTROTHERAPY DEVICE (COMBO UNIT) | Dec 20, 2013 | Substantially Equivalent | Guangzhou Finecure Medical Equipment Co.,Ltd |
| K130052 | TONE-A-MATIC | Dec 20, 2013 | Substantially Equivalent | Tone-A-Matic International, Inc. |
| K131629 | NEURODYN MULTIWAVE, AUSSIE SPORT | Nov 26, 2013 | Substantially Equivalent | Ibramed Equipamentos Medicos |
| K131222 | AMPCARE ESP THERAPY SYSTEM | Oct 31, 2013 | Substantially Equivalent | Ampcare, LLC |
| K132137 | MULTISTIM | Sep 12, 2013 | Substantially Equivalent | Metron Medical Australia, Pty, Ltd. |
| K130424 | STIMEL-03 | Jul 11, 2013 | Substantially Equivalent | Stimel, Ltd. |
| K123354 | REVITIVE IX | Jun 28, 2013 | Substantially Equivalent | Actegy , Ltd. |
| K124016 | EMPI PHOENIX | May 06, 2013 | Substantially Equivalent | Djo, LLC |
| K123642 | MUSCLE STIMULATION SYSTEM | Mar 29, 2013 | Substantially Equivalent | Niveus Medical, Inc. |
| K120922 | GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT | Feb 07, 2013 | Substantially Equivalent | Selectivemed Components, Inc. |
| K113010 | FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR | Dec 21, 2012 | Substantially Equivalent | Famidoc Technology Co., Ltd. |
| K113017 | SYS*STIM 240 | Jun 26, 2012 | Substantially Equivalent | Mettler Electronics Corp. |
| K112148 | POWERED MUSCLE STIMULATOR | Apr 30, 2012 | Substantially Equivalent | Valmed, SA |
| K112348 | RS-4I MUSCLE STIMULATOR | Jan 19, 2012 | Substantially Equivalent | Rs Medical |
| K111279 | NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM | Sep 20, 2011 | Substantially Equivalent | Zynex Medical, Inc. |
| K103738 | H-WAVE | Jun 01, 2011 | Substantially Equivalent | Electronic Waveform Laboratory, Inc. |
| K100862 | BODYFLOW P2CH | Apr 21, 2011 | Substantially Equivalent | Physiomed Elektromedizin AG |
| K092202 | ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT | Feb 10, 2011 | Substantially Equivalent | Eswallow USA |
| K102202 | GS 3000 | Nov 23, 2010 | Substantially Equivalent | Emsi |
| K093324 | EMPI CONTINUUM | Mar 05, 2010 | Substantially Equivalent | Empi |
| K093138 | MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003 | Feb 12, 2010 | Substantially Equivalent | Shenzhen Dongdixin Technology Co., Ltd. |
| K100117 | LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR | Jan 29, 2010 | Substantially Equivalent | Shenzhen Dongdixin Technology Co., Ltd. |
| K092791 | KNEEHAB XP CONTROLLER, MODEL 411 | Dec 30, 2009 | Substantially Equivalent | Bio-Medical Research, Ltd. |
| K093259 | ARP RX100 | Dec 17, 2009 | Substantially Equivalent | Arp Manufacturing, Inc. |
| K091248 | MAXEMS, MODELS 1000 AND 2000 | Nov 30, 2009 | Substantially Equivalent | Bio Protech, Inc. |
| K090532 | T.E.A.R. TECH3 | Nov 13, 2009 | Substantially Equivalent | Vision Quest Industries, Inc. |
| K083105 | KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411 | Jul 24, 2009 | Substantially Equivalent | Bio-Medical Research, Ltd. |
| K090632 | COMPEX REHAB | Jun 01, 2009 | Substantially Equivalent | Chattanooga Group |
| K080950 | STIWELL MED4 | Apr 02, 2009 | Substantially Equivalent | Otto Bock, Austria GmbH |
| K071677 | SRT II MUSCLE STIMULATOR | Jul 11, 2008 | Substantially Equivalent | Therapeutic Innovations, Inc. |
| K070888 | COMBI 8 MAX | Jul 03, 2008 | Substantially Equivalent | Cec Electronica S.R.L. |
| K080787 | BIOMOVE 5000 SYSTEM | Apr 17, 2008 | Substantially Equivalent | Curatronic, Ltd. |
| K080661 | MODELS TENS 7000, EMS 7500 AND TWIN STIM | Mar 24, 2008 | Substantially Equivalent | Koalaty Products, Inc. |
| K073361 | MUSCLE PAIN DEVICE (MPD) | Mar 18, 2008 | Substantially Equivalent | Stevens Proof of Concept, Inc. |
| K072252 | VEINOPLUS NEUROMUSCULAR STIMULATOR | Jan 30, 2008 | Substantially Equivalent | Ad Rem Technology Sarl |
| K063642 | FD EMS, MODEL # D-FJ30E | Dec 13, 2007 | Substantially Equivalent | Fuji Dynamics Limited |
| K071093 | SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202 | Dec 06, 2007 | Substantially Equivalent | San Shih Electrical Enterprise Co., Ltd. |
| K072795 | MODELS EMS 5.0, EMS 5.1 | Nov 27, 2007 | Substantially Equivalent | Koalaty Products, Inc. |
| K071431 | GLOBUS GENESY 1100 STIMULATOR | Sep 21, 2007 | Substantially Equivalent | Domino S.R.L. |
| K071320 | EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311 | Aug 17, 2007 | Substantially Equivalent | Everlife Medical Equipment Co., Ltd. |
| K070425 | VITALSTIM EXPERIA | Jun 11, 2007 | Substantially Equivalent | Chattanooga Group |
| K062453 | KINGLY STAR POWERED MUSCLE STIMULATOR, MODEL KS-138 | Apr 17, 2007 | Substantially Equivalent | Kingly Star Intl. Technology Co., Ltd. |
| K062354 | VECTRA GENISYS VMS FR | Jan 26, 2007 | Substantially Equivalent | Encore Medical L.P. |
| K053285 | MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM | Jan 05, 2006 | Substantially Equivalent | Durtech System Corp. |
| K053266 | MYOTRAC INFINITI | Dec 29, 2005 | Substantially Equivalent | Thought Technology , Ltd. |
| K050921 | EASYSTIM NMS-28 | Dec 12, 2005 | Substantially Equivalent | Easy Med Instrument Co., Ltd. |
| K051135 | AXIOM NVP8500 | Aug 11, 2005 | Substantially Equivalent | Axiom Worldwide, Inc. |
| K050687 | AXIOM EPS8000 | Jul 28, 2005 | Substantially Equivalent | Axiom Worldwide, Inc. |
| K050847 | IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A | Jun 17, 2005 | Substantially Equivalent | Theratech, Inc. |
| K050595 | FT2000 SEQUENCER FOR MUSCLE STIMULATOR | May 23, 2005 | Substantially Equivalent | Midwest Development |
| K050046 | REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S | Apr 13, 2005 | Substantially Equivalent | Compex Technologies, Inc. |
| K024258 | NEUROTECH KNEEHAB | Mar 04, 2005 | Substantially Equivalent | Bio-Medical Research, Ltd. |
| K041390 | DIAMOND MEDISTIM | Feb 09, 2005 | Substantially Equivalent | Diamond Systems USA, Inc. |
| K042650 | BIOMOVE 3000 | Jan 27, 2005 | Substantially Equivalent | Curatronic, Ltd. |
| K041920 | INFINITY PLUS ELECTROTHERAPY SYSTEM | Jan 21, 2005 | Substantially Equivalent | Empi |
| K041063 | SMARTWAVE MS 2000 | Dec 01, 2004 | Substantially Equivalent | Newwave Medical, LLC |
| K042881 | PMD-2000 INTERFERENTIAL STIMULATOR | Nov 18, 2004 | Substantially Equivalent | Phoenix Medical Devices, LLC |
| K034005 | SDS-4I | Nov 18, 2004 | Substantially Equivalent | Skylark Device & Systems Co., Ltd. |
| K040849 | MENTAMOVE | Oct 01, 2004 | Substantially Equivalent | Cole & Associates |
| K032954 | ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80 | Aug 09, 2004 | Substantially Equivalent | Danmeter A/S |
| K033174 | BMLS03-3 | Jun 30, 2004 | Substantially Equivalent | Biomedical Life Systems, Inc. |
| K041146 | CONTROL SOLUTIONS, INC., MODEL CS3102 HVG | Jun 08, 2004 | Substantially Equivalent | Control Solutions, Inc. |
| K031310 | TAI SHENG VARIOUS NEOX POWERED MUSCLE STIMULATOR | Apr 12, 2004 | Substantially Equivalent | Tai Sheng Electrical Machinery Co., Ltd. |
| K040306 | HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7 | Mar 23, 2004 | Substantially Equivalent | Biomedical Life Systems, Inc. |
| K032955 | AUTOMOVE, MODEL AM800 | Dec 15, 2003 | Substantially Equivalent | Danmeter A/S |
| K033544 | ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607 | Dec 10, 2003 | Substantially Equivalent | Everyway Medical Instruments Co.,Ltd |
| K031375 | BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580 | Nov 20, 2003 | Substantially Equivalent | Besmed Health Business Corp |
| K031820 | ELECTRONIC MUSCLE MASSAGE, MODELS BE-550 AND BE-660 | Nov 12, 2003 | Substantially Equivalent | Multinational |
| K033140 | NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P | Oct 29, 2003 | Substantially Equivalent | Everyway Medical Instruments Co.,Ltd |
| K023000 | HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES | Oct 29, 2003 | Substantially Equivalent | Home Care Technology Co., Ltd. |
| K032941 | AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE | Oct 22, 2003 | Substantially Equivalent | Rich-Mar Corp. |
| K032178 | RHYTHM TOUCH Q 2-WAY | Oct 15, 2003 | Substantially Equivalent | Shockim Enterprises, Ltd. |
| K030998 | MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-300 | Oct 10, 2003 | Substantially Equivalent | Healthonics, Inc. |
| K032652 | RS-4I MUSCLE STIMULATOR FAMILY | Sep 12, 2003 | Substantially Equivalent | Rs Medical |
| K031427 | ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1 | Aug 19, 2003 | Substantially Equivalent | Biomedical Life Systems, Inc. |
| K030403 | CEFAR REHAB 2 AND REHAB 2 PRO | Jul 17, 2003 | Substantially Equivalent | Cefar Medical AB |
| K020478 | ELECTROMEDICARIN 900 | Jul 17, 2003 | Substantially Equivalent | Electromedicarin, S.A. |
| K031884 | INTERFERENTIAL STIMULATOR, MODEL NETWAVE | Jun 30, 2003 | Substantially Equivalent | Ryan Telemedicine |
| K024181 | PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM | Jun 26, 2003 | Substantially Equivalent | Prizm Medical, Inc. |
| K023036 | CARE ETS | Jun 19, 2003 | Substantially Equivalent | Care Rehab and Orthopaedic |
| K031017 | SYS*STIM 208 AND 208A | May 30, 2003 | Substantially Equivalent | Mettler Electronics Corp. |
| K030507 | T.E.A.R. TECH3 MODEL #44TT03 | May 20, 2003 | Substantially Equivalent | Vision Quest Industries, Inc. |
| K022998 | HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312 | May 20, 2003 | Substantially Equivalent | Home Care Technology Co., Ltd. |
| K023230 | ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800 | May 05, 2003 | Substantially Equivalent | Western Clinical Technology Systems, Inc. |
| K023001 | HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L | Apr 08, 2003 | Substantially Equivalent | Home Care Technology Co., Ltd. |
| K030648 | VECTORSURGE 5 MODEL 470 | Mar 28, 2003 | Substantially Equivalent | Metron Medical Australia, Pty, Ltd. |
| K023997 | TENSCARE ULTIMA NMS/EMS | Mar 03, 2003 | Substantially Equivalent | Tenscare, Ltd. |
| K030254 | INTERFERENTIAL STIMULATOR, MODEL RTM1000 | Feb 26, 2003 | Substantially Equivalent | Ryan Telemedicine |
| K021588 | ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS02-5 | Feb 13, 2003 | Substantially Equivalent | Biomedical Life Systems, Inc. |
| K023446 | MEDS-3 NEUROMUSCULAR STIMULATOR | Jan 13, 2003 | Substantially Equivalent | Medical Equipment Device Specialists |
| K023439 | MEDS-4 NEUROMUSCULAR STIMULATOR | Jan 13, 2003 | Substantially Equivalent | Medical Equipment Device Specialists |
| K024036 | PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000 | Dec 20, 2002 | Substantially Equivalent | Johari Digital Healthcare , Ltd. |
| K023347 | VITAL STIM | Dec 06, 2002 | Substantially Equivalent | Chattanooga Group |
| K020130 | ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M | Dec 02, 2002 | Substantially Equivalent | Rolor Electronics Corp. |
| K020750 | DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS | Oct 31, 2002 | Substantially Equivalent | Everyway Medical Instruments Co.,Ltd |
| K022493 | EMS 400 | Oct 11, 2002 | Substantially Equivalent | Body Clock Health Care, Ltd. |
| K022776 | NESS SYSTEM | Sep 11, 2002 | Substantially Equivalent | Ness-Neuromuscular Electrical Stimulation Systems |
| K022175 | P4 PHYSIO | Sep 09, 2002 | Substantially Equivalent | Valmed Corp. |
| K021905 | CLASSIC NMS | Sep 05, 2002 | Substantially Equivalent | Care Rehab, Inc. |
| K021472 | HMS-DHR-3 NEUROMUSCULAR STIMULATOR | Aug 06, 2002 | Substantially Equivalent | Home Medical Services |
| K014019 | NEUROTECH MEDISTIM PLUS, TYPE 291 | Jul 11, 2002 | Substantially Equivalent | Bio-Medical Research, Ltd. |
| K013768 | POWERED MUSCLE STIMULATOR | Jul 03, 2002 | Substantially Equivalent | Theratech, Inc. |
| K021754 | APEX MEDICAL DIGITAL EMS TS1311, TS1312 | Jun 28, 2002 | Substantially Equivalent | Apex Medical Corp. |
| K021100 | 300 PV COMPLETE ELECTROTHERAPY SYSTEM | Jun 18, 2002 | Substantially Equivalent | Empi |
| K021763 | RS2MI MUSCLE STIMULATOR FAMILY | Jun 13, 2002 | Substantially Equivalent | Rs Medical |
| K020637 | SELECT STIM | May 28, 2002 | Substantially Equivalent | Care Rehab and Orthopaedic |
| K020684 | FINESUN EMS STIMULATOR | May 23, 2002 | Substantially Equivalent | Finesun Worldwide Intl. Co., Ltd. |
| K020314 | DIGI-PRO TENS, MODEL WL-2204 AND WL-2205 | Apr 30, 2002 | Substantially Equivalent | Well-Life Healthcare, Inc. |
| K011588 | SURETONE | Mar 28, 2002 | Substantially Equivalent | Suretone International |
| K992099 | BIO SPA INTELLIGENT | Jan 18, 2002 | Substantially Equivalent | Starbene |
| K013771 | MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE | Jan 18, 2002 | Substantially Equivalent | Rich-Mar Corp. |
| K013770 | MODIFICATION TO: WINNER ST-2 STIMULATOR | Jan 18, 2002 | Substantially Equivalent | Rich-Mar Corp. |
| K013081 | MEDSTAR 150 | Nov 20, 2001 | Substantially Equivalent | Mednet Services, Inc. |
| K012885 | NEUROMOVE NM900 | Nov 08, 2001 | Substantially Equivalent | Dan Med, Inc. |
| K011913 | SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES | Oct 26, 2001 | Substantially Equivalent | Sun-Rain System Corp. |
| K000741 | EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-188 | Oct 24, 2001 | Substantially Equivalent | 138 Medical Supplies, Inc. |
| K010749 | ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL | Sep 28, 2001 | Substantially Equivalent | Biomedical Life Systems, Inc. |
| K002339 | AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600 | Aug 24, 2001 | Substantially Equivalent | Apex Medical Corp. |
| K010807 | MUSCLE STIMULATOR SA-100 | Aug 09, 2001 | Substantially Equivalent | Health@Fitness Technologies, Inc. |
| K002336 | MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T | Jul 27, 2001 | Substantially Equivalent | Apex Medical Corp. |
| K010745 | EMS 3000 | Jun 27, 2001 | Substantially Equivalent | Dan Med, Inc. |
| K003433 | NEURO-TRAIN III (3) | Jun 15, 2001 | Substantially Equivalent | Sterne Equipment Co., Ltd. |
| K003596 | SMITH & NEPHEW RESTIM | Jun 06, 2001 | Substantially Equivalent | Smith & Nephew, Inc. |
| K002410 | FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE | Jun 06, 2001 | Substantially Equivalent | Dysphagia, LLC |
| K002058 | VECTORSURGE 5, MODEL VS-500 | May 29, 2001 | Substantially Equivalent | Metron Medical Australia, Pty, Ltd. |
| K010665 | TRANSAMERICA DIGITAL EMS | Apr 27, 2001 | Substantially Equivalent | Transamerica Medical Systems |
| K003260 | VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460 | Feb 22, 2001 | Substantially Equivalent | Metron Medical Australia, Pty, Ltd. |
| K000808 | RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE | Aug 25, 2000 | Substantially Equivalent | Rich-Mar Corp. |
| K000114 | RS-4M+MUSCLE STIMULATOR | Aug 10, 2000 | Substantially Equivalent | Rs Medical |
| K993420 | CONTROL SOLUTIONS INC, MODEL CS3101 | Jul 19, 2000 | Substantially Equivalent | Control Solutions, Inc. |
| K994062 | HMS NEUROMUSCULAR STIMULATOR | Apr 10, 2000 | Substantially Equivalent | Home Medical Services, Inc. |
| K994065 | MS-ONE, MODEL MS-1 | Apr 04, 2000 | Substantially Equivalent | Home Wellness West |
| K993821 | VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT | Dec 09, 1999 | Substantially Equivalent | Metron Medical Australia, Pty, Ltd. |
| K991241 | IF8000 | Nov 02, 1999 | Substantially Equivalent | Dan Med, Inc. |
| K990787 | TRIO 300 | Oct 20, 1999 | Substantially Equivalent | Ito Co., Ltd. |
| K990697 | RS-4V MUSCLE STIMULATOR | Jun 18, 1999 | Substantially Equivalent | Rs Medical |
| K984142 | SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER ME 994 | Feb 09, 1999 | Substantially Equivalent | Mettler Electronics Corp. |
| K984114 | SYS STIM 294, MODEL ME 294 | Feb 09, 1999 | Substantially Equivalent | Mettler Electronics Corp. |
| K984113 | MS400 | Jan 28, 1999 | Substantially Equivalent | Lsi Intl., Inc. |
| K984021 | MS300 | Jan 28, 1999 | Substantially Equivalent | Lsi Intl., Inc. |
| K982828 | FORTE, MODELS CPS 400 STIM, CPS 200 STIM | Nov 06, 1998 | Substantially Equivalent | Chattanooga Group, Inc. |
| K982482 | HANDMASTER NMS1 | Sep 30, 1998 | Substantially Equivalent | N.E.S.S. Nuromuscular Electrical Stimulation Syst |
| K982388 | SURGI STIM | Sep 14, 1998 | Substantially Equivalent | Vision Quest Industries, Inc. |
| K980158 | MYO-TRAIN V (5) | Jul 28, 1998 | Substantially Equivalent | Sterne Equipment Co., Ltd. |
| K980040 | ELECTRONIC MUSCLE STIMULATOR - MICROSTIM J-1304D | Jul 13, 1998 | Substantially Equivalent | Nisha Communication Industries |
| K973929 | NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM | May 21, 1998 | Substantially Equivalent | Neotonus, Inc. |
| K980958 | HAKOMED ELECDT/VACUPULLS | May 11, 1998 | Substantially Equivalent | Alive, Inc. |
| K980892 | HAKOMED ELECDT / PRO ELEDT SERIES | May 11, 1998 | Substantially Equivalent | Alive, Inc. |
| K980346 | ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000) | Apr 28, 1998 | Substantially Equivalent | Universal Technology Systems, Inc. |
| K980448 | MODEL PS-1 PENA MUSCLE STIMULATOR | Apr 03, 1998 | Substantially Equivalent | Radionics, Inc. |
| K973223 | STELLAR MODEL HS-04 | Feb 18, 1998 | Substantially Equivalent | Stellar Medical Corp. |
| K972997 | AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION | Nov 10, 1997 | Substantially Equivalent | Dan Med, Inc. |
| K964434 | SD-970EMS ELECTRICAL MUSCULAR STIMULATOR | Oct 09, 1997 | Substantially Equivalent | Skylark Device Co., Ltd. |
| K961751 | W.M.E. GPS 1001 | Sep 25, 1997 | Substantially Equivalent | Weaver Medical Electronics, Inc. |
| K970847 | IMPULSE HVG | Sep 10, 1997 | Substantially Equivalent | Armstrong Industries, Inc. |
| K972055 | MSI MAGNA-STYM | Aug 29, 1997 | Substantially Equivalent | Microvas Systems, Inc. |
| K971542 | ORTHO DX NEUROMUSCULAR STIMULATOR | Aug 14, 1997 | Substantially Equivalent | Rehabilicare, Inc. |
| K955666 | EGS4000 | Apr 15, 1997 | Substantially Equivalent | S&P Electrical Industries, Inc. |
| K970155 | NEURO-TRAIN II (2) | Mar 17, 1997 | Substantially Equivalent | Sterne Equipment Co., Ltd. |
| K964028 | SYS STIM 226 | Feb 03, 1997 | Substantially Equivalent | Mettler Electronics Corp. |
| K964423 | AXIOM INF | Jan 24, 1997 | Substantially Equivalent | Axiom Manufacturing |
| K950550 | XH-1 NEUROMUSCULAR STIMULATOR | Dec 04, 1996 | Substantially Equivalent | California Medical Research Institute |
| K962462 | MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR | Sep 23, 1996 | Substantially Equivalent | Smith and Nephew Donjoy, Inc. |
| K960457 | ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C | Sep 06, 1996 | Substantially Equivalent | Med Labs, Inc. |
| K952273 | HANDMASTER NMS1 | May 23, 1996 | Substantially Equivalent | Neuromusclar Electrical Stimulation Systems, Ltd. |
| K955736 | STIM-8 | May 22, 1996 | Substantially Equivalent for Some Indications | Bmr , Ltd. |
| K960433 | VST-10, VST-10/2 | May 21, 1996 | Substantially Equivalent for Some Indications | Vcare Intl., Inc. |
| K955146 | AXIOM-HVG | May 17, 1996 | Substantially Equivalent for Some Indications | Axiom Manufacturing |
| K960489 | ULTRA IV | Mar 27, 1996 | Substantially Equivalent for Some Indications | Excel Tech. , Ltd. |
| K960096 | ULTRA III | Mar 27, 1996 | Substantially Equivalent for Some Indications | Excel Tech. , Ltd. |
| K954411 | GALVA-5-M | Feb 28, 1996 | Substantially Equivalent for Some Indications | Zimmer Elektromedizin GmbH |
| K951682 | OCTOSTIM | Dec 11, 1995 | Substantially Equivalent for Some Indications | Freiler |
| K952680 | VARAPULSE-2 | Dec 04, 1995 | Substantially Equivalent | Staodyne, Inc. |
| K953136 | RS-4M | Nov 30, 1995 | Substantially Equivalent for Some Indications | Rs Medical |
| K951727 | Z-WATCH SYSTEM | Nov 21, 1995 | Substantially Equivalent for Some Indications | Prizm Medical, Inc. |
| K953615 | FORTE ES-400 | Oct 27, 1995 | Substantially Equivalent for Some Indications | Chattanooga Group, Inc. |
| K950783 | 4000+ | Oct 27, 1995 | Substantially Equivalent for Some Indications | U.S. Therapy Products, Inc. |
| K943007 | ITP-HVPC GALVANIC STIMULATOR | Oct 26, 1995 | Substantially Equivalent for Some Indications | Innovative Therapy Products, Inc. |
| K950617 | SMART WAVE GS100 | Oct 13, 1995 | Substantially Equivalent for Some Indications | Shotwell & Carr, Inc. |
| K946186 | CHAL-2500 | Aug 14, 1995 | Substantially Equivalent for Some Indications | Hogan & Hartson |
| K943185 | BX-200 SC | Aug 14, 1995 | Substantially Equivalent for Some Indications | Bloomex International, Inc. |
| K942195 | BX-400S | Aug 14, 1995 | Substantially Equivalent for Some Indications | Bloomex International, Inc. |
| K944935 | DYNATRON 250 | Jun 22, 1995 | Substantially Equivalent for Some Indications | Dynatronics Corp. |
| K946298 | BIOSTIM-HV | May 11, 1995 | Substantially Equivalent | Progressive Concepts, Inc. |
| K932075 | MASTERSTIM 1-4 | May 10, 1995 | Substantially Equivalent | Health Care Assoc. |
| K945510 | FX-4 NMS (4CHANNEL TABLE MODEL) | May 02, 1995 | Substantially Equivalent | Fx-2 |
| K945509 | FX-2 NMS (2CHANNEL TABLE MODEL) | May 02, 1995 | Substantially Equivalent | Fx-2 |
| K945508 | FX-2P NMS (2 CHANNEL PORTABLE) | May 02, 1995 | Substantially Equivalent | Fx-2 |
| K940301 | COMPEX 2 | Dec 28, 1994 | Substantially Equivalent for Some Indications | Biodex Medical Systems, Inc. |
| K934556 | EMS-250 | Nov 08, 1994 | Substantially Equivalent | Electronic Medical Sciences, Inc. |
| K933194 | THE SIGNATURE SERIES, IMC IV | Jul 13, 1994 | Substantially Equivalent | Progressive Electrical Therapeutics |
| K933196 | THE SIGNATURE SERIES, IC II | Jul 12, 1994 | Substantially Equivalent | Progressive Electrical Therapeutics |
| K941049 | MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR | May 19, 1994 | Substantially Equivalent for Some Indications | Smith & Nephew, Inc. |
| K934919 | THE SIGNATURE SERIES, MAGNUM 100 | Apr 06, 1994 | Substantially Equivalent | Progressive Electrical Therapeutics |
| K940349 | NEUROMUSCULAR ELECTRICAL STIMULATOR | Apr 01, 1994 | Substantially Equivalent | Progressive Concepts, Inc. |
| K933653 | MS 2500 | Mar 23, 1994 | Substantially Equivalent | Lsi Intl., Inc. |
| K931401 | EMS | Mar 23, 1994 | Substantially Equivalent | Saratoga Intl., Inc. |
| K932898 | POWERED MUSCLE STIMULATOR | Mar 15, 1994 | Substantially Equivalent | Nemectron GmbH |
| K926084 | HVGS 9000 | Mar 14, 1994 | Substantially Equivalent | Shevlin Medical, Inc. |
| K933195 | THE SIGNATURE SERIES, IC IV | Feb 23, 1994 | Substantially Equivalent for Some Indications | Progressive Electrical Therapeutics |
| K932916 | GALVANIC GENERATOR MODEL IMF4150/A | Jan 07, 1994 | Substantially Equivalent | Biomedical Life Systems, Inc. |
| K932739 | FAST START NEUROMUSCULAR STIMULATOR | Jan 07, 1994 | Substantially Equivalent for Some Indications | Madeoutback Co. , Ltd. |
| K933072 | PCI 2500 | Oct 28, 1993 | Substantially Equivalent | Pci |
| K933249 | DYNATRON 100 PLUS | Oct 08, 1993 | Substantially Equivalent | Dynatronics Research Corp. |
| K933176 | NEUROTECH 2000 (NT2000) | Oct 08, 1993 | Substantially Equivalent | Bmr Ent., Inc. |
| K931781 | JACE TRI-STIM DEVICE | Oct 08, 1993 | Substantially Equivalent | Jace Systems, Inc. |
| K932764 | THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P) | Oct 01, 1993 | Substantially Equivalent | Myo/Kinetic Systems, Inc. |
| K932610 | PCI 4000 | Aug 19, 1993 | Substantially Equivalent | Pci |
| K932596 | NT4-PLUS | Aug 12, 1993 | Substantially Equivalent | Bmr Ent., Inc. |
| K932399 | THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P) | Aug 11, 1993 | Substantially Equivalent | Myo/Kinetic Systems, Inc. |
| K926510 | STAODYN EMS+2 | Aug 11, 1993 | Substantially Equivalent | Staodyne, Inc. |
| K926410 | ULTRATONE 8+ & 20 | Aug 11, 1993 | Substantially Equivalent | Bowater Research, Inc. |
| K926265 | NEURO-CARE 1000 | Aug 03, 1993 | Substantially Equivalent | Ems Northwest |
| K930670 | PHYACTION 787 | Jul 02, 1993 | Substantially Equivalent | Verimed Holdings, Inc. |
| K924699 | PMP MUSCLE STIMULATOR | Apr 30, 1993 | Substantially Equivalent | Preferred Medical Products |
| K923501 | HIGH VOLT UNIT | Mar 04, 1993 | Substantially Equivalent | Willows Health Center |
| K923498 | BIPHASIC UNIT | Mar 04, 1993 | Substantially Equivalent | Willows Health Center |
| K925680 | LSI SYSTEM IV INTERFERENTIAL,MUSCLE STIMULATOR | Mar 02, 1993 | Substantially Equivalent | M.S.P. , Ltd. |
| K920389 | RS-2 NEUROMUSCULAR STIMULATOR | Jan 28, 1993 | Substantially Equivalent | Rs Medical |
| K920388 | RS-1 NEUROMUSCULAR STIMULATOR | Jan 28, 1993 | Substantially Equivalent | Rs Medical |
| K923914 | IF-II (TM), MODEL 7200 | Nov 06, 1992 | Substantially Equivalent | Medical Devices, Inc. |
| K912328 | ELECTRONIC MUSCLE STIMULATORS, EXCEL II, MODIFIED | Nov 06, 1992 | Substantially Equivalent | Advanced Rehabilitative Technology, Inc. |
| K921668 | STAODYN TUWAVE | Aug 03, 1992 | Substantially Equivalent | Staodyne, Inc. |
| K920532 | ACU-TRAIN V (5) | Jul 17, 1992 | Substantially Equivalent | Sterne Medical Equipment Div. Ontario , Ltd. |
| K915321 | BTM-200 (PROPOSED) POWERED MUSCLE STIMULATOR | Jul 17, 1992 | Substantially Equivalent | Bt Medical Co., Inc. |
| K912462 | Q-MS NEUROMUSCULAR STIMULATOR | Jun 04, 1992 | Substantially Equivalent | Quantitative Medicine, Inc. |
| K914231 | ELPHA 2000 | May 28, 1992 | Substantially Equivalent | Biometer Intl. A/S |
| K920833 | RICH-MAR HV 1000 MUSCLE STIMULATOR | May 22, 1992 | Substantially Equivalent for Some Indications | Rich-Mar Corp. |
| K920436 | MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR | May 20, 1992 | Substantially Equivalent | Medtronic Vascular |
| K915230 | H WAVE MUSCLE STIMULATOR | May 08, 1992 | Substantially Equivalent | Electronic Waveform Laboratory, Inc. |
| K914904 | THERAPEUTIC STIMULATOR 2100 (TS-2100) | Apr 28, 1992 | Substantially Equivalent | Myo/Kinetic Systems, Inc. |
| K914999 | BTM-100 POWERED MUSCLE STIMULATOR (PROPOSED) | Apr 23, 1992 | Substantially Equivalent | Bt Medical Co., Inc. |
| K903870 | KINESTHETICS MODEL 2000 NMS | Mar 13, 1992 | Substantially Equivalent | Kinesthetics, Inc. |
| K904509 | POWER TRAINER WITH NEUROMUSCULAR STIMULATION | Feb 12, 1992 | Substantially Equivalent | Sinties Scientific, Inc. |
| K914539 | RICH-MAR IFV 1000 | Dec 18, 1991 | Substantially Equivalent | Rich-Mar Corp. |
| K903148 | CHALLENGE 3000 NEUROLOGICAL BOOSTER | Dec 10, 1991 | Substantially Equivalent | Maximum Performance Technologies, Mpts, Inc. |
| K912642 | EMS300, EMS400, EMS8000 | Dec 09, 1991 | Substantially Equivalent | Skylark Device Co., Ltd. |
| K912342 | DR. LIBERSON'S MICROPULSE NEUROMUSCULAR TRANS STIM | Dec 09, 1991 | Substantially Equivalent | Amer Inst of Electrodiagnosis/Electrotherapy, Inc. |
| K913444 | GLOBALCARE EMS | Oct 21, 1991 | Substantially Equivalent | Globalcare Intl., Inc. |
| K904360 | CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR | Oct 15, 1991 | Substantially Equivalent | Maximum Performance Technologies, Mpts, Inc. |
| K910801 | HIGH VOLTAGE PULSED GALVANIC STIMULATION APPLICATI | Sep 04, 1991 | Substantially Equivalent | Psychoenergetic Systems, Inc. |
| K913272 | EMS/400 | Aug 22, 1991 | Substantially Equivalent | Altoona Medical Supply |
| K905107 | UTS ELECTRICAL MUSCLE STIMULATION DEVICE-PGS 1500 | Aug 19, 1991 | Substantially Equivalent | Universal Technology Systems, Inc. |
| K904332 | MSTIM-2000 EMS | May 01, 1991 | Substantially Equivalent | Oms Medical Supplies, Inc. |
| K903711 | RHEOLOGIC I | Jan 16, 1991 | Substantially Equivalent | Advanced Rehabilitative Technology, Inc. |
| K903149 | CHANLLENGE 1010 PATIENT KEY PROGRAM STATION | Nov 05, 1990 | Substantially Equivalent | Maximum Performance Technologies, Mpts, Inc. |
| K902255 | OMRON PULSE STIMULATOR MODEL HV-F05 | Oct 31, 1990 | Substantially Equivalent | Omron Electronics, Inc. |
| K902599 | REVISED HIGH VOLTAGE STIMULATOR INTELECT 150 | Oct 22, 1990 | Substantially Equivalent | Chattanooga Group, Inc. |
| K900647 | SOUTHERN CROSS HI-V4 PULSED HIGH VOLTAGE GALVANIC | Oct 22, 1990 | Substantially Equivalent | Nor-Am Patient Care Products, Inc. |
| K902371 | HAELAN 340 MUSCLE STIMULATOR | Sep 12, 1990 | Substantially Equivalent | Paranamics, Inc. |
| K902514 | CHALLENGE 5010 POWERED MUSCLE STIMULATOR | Aug 31, 1990 | Substantially Equivalent | Maximum Performance Technologies, Mpts, Inc. |
| K902513 | CHALLENGE 6010 POWERED MUSCLE STIMULATOR | Aug 31, 1990 | Substantially Equivalent | Maximum Performance Technologies, Mpts, Inc. |
| K902512 | CHALLENGE 8000 POWERED MUSCLE STIMULATOR | Aug 31, 1990 | Substantially Equivalent | Maximum Performance Technologies, Mpts, Inc. |
| K902511 | CHALLENGE 7010 POWERED MUSCLE STIMULATOR | Aug 31, 1990 | Substantially Equivalent | Maximum Performance Technologies, Mpts, Inc. |
| K901849 | LUMISCOPE EMS 8000 | Aug 24, 1990 | Substantially Equivalent | Lumiscope Co., Inc. |
| K893980 | LINDQUIST MODEL 370 | Aug 02, 1990 | Substantially Equivalent | R.J. Lindquist Co. |
| K892960 | LINDQUIST MODEL SS POWERED MUSCLE STIMULATOR | Aug 02, 1990 | Substantially Equivalent | R.J. Lindquist Co. |
| K901770 | CHALLENGE 7000 POWERED MUSCLE STIMULATOR | Jul 03, 1990 | Substantially Equivalent | Maximum Performance Technologies, Mpts, Inc. |
| K901769 | CHALLENGE 6000 POWERED MUSCLE STIMULATOR | Jul 03, 1990 | Substantially Equivalent | Maximum Performance Technologies, Mpts, Inc. |
| K901768 | CHALLENGE 5000 POWERED MUSCLE STIMULATOR | Jul 03, 1990 | Substantially Equivalent | Maximum Performance Technologies, Mpts, Inc. |
| K901779 | RICH-MAR BP-2000 ELECTRICAL MUSCLE STIMULA. UNIT | Jun 26, 1990 | Substantially Equivalent | Rich-Mar Corp. |
| K901326 | CHALLENGE 20 POWERED MUSCLE STIMULATOR | May 29, 1990 | Substantially Equivalent | Maximum Performance Technologies, Mpts, Inc. |
| K881431 | SIEMENS STEREODYNATOR 828 | Apr 16, 1990 | Substantially Equivalent | Elmed, Inc. |
| K900029 | SPECTRASTIM 2000 MUSCLE STIMULATOR | Apr 02, 1990 | Substantially Equivalent | Therapeutic Technologies, Inc. |
| K900823 | ISOTRON 220 | Mar 26, 1990 | Substantially Equivalent | Excel Tech. , Ltd. |
| K900413 | INTELECT 775MP POWERED MUSCLE STIMULATOR | Mar 07, 1990 | Substantially Equivalent | Chattanooga Group, Inc. |
| K893220 | VERIMED MYOEXORCISER VERISTIM | Mar 07, 1990 | Substantially Equivalent | Verimed Holdings, Inc. |
| K896908 | EXCEL STIM II | Feb 20, 1990 | Substantially Equivalent | Excel U.S.A. |
| K896836 | EXCEL STIM | Feb 20, 1990 | Substantially Equivalent | Excel Tech. , Ltd. |
| K895983 | MULTISTIM PLUS | Feb 20, 1990 | Substantially Equivalent | Excel Tech. , Ltd. |
| K895301 | EMS 8100 | Feb 20, 1990 | Substantially Equivalent | Henley Intl. |
| K891987 | BIO-STYM 250 (MUSCLE STIMULATOR) | Jan 04, 1990 | Substantially Equivalent | Electronic Health Technologies, Inc. |
| K895760 | ELECTRICAL MUSCLE STIMULATOR--PGS 2000 TENS DEVICE | Jan 02, 1990 | Substantially Equivalent | Universal Technology Systems, Inc. |
| K893879 | SYS*STIM 207A | Dec 19, 1989 | Substantially Equivalent | Mettler Electronics Corp. |
| K893878 | SYS*STIM 206A | Dec 19, 1989 | Substantially Equivalent | Mettler Electronics Corp. |
| K893994 | IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT | Dec 14, 1989 | Substantially Equivalent | Rich-Mar Corp. |
| K895671 | STIMTRAC II CATALOG NUMBER 78-8500 | Nov 06, 1989 | Substantially Equivalent | Stimtech Products |
| K893851 | THERASTIM | Nov 06, 1989 | Substantially Equivalent | Physiodynamics, Inc. |
| K884651 | ELECTRO NEUROMUSCULAR STIMULATOR MODEL 2000 | Nov 06, 1989 | Substantially Equivalent | Biomedical Life Systems, Inc. |
| K891458 | SW 803 LOW FREQUENCY STIMULATOR DANA TOUCH | Oct 20, 1989 | Substantially Equivalent | Back IN Action, Inc. |
| K882386 | AGAR 3K NEUROMUSCULAR STIMULATOR | Oct 18, 1989 | Substantially Equivalent | Solcoor, Inc. |
| K890434 | EMS 300 MUSCLE STIMULATORS | Oct 17, 1989 | Substantially Equivalent | Paranamics, Inc. |
| K882387 | AGAR 4000 NEUROMUSCULAR STIMULATOR | Oct 16, 1989 | Substantially Equivalent | Solcoor, Inc. |
| K881777 | LIKON | Oct 16, 1989 | Substantially Equivalent | Northwood Intl., Corp. |
| K893964 | SPECTRASTIM TM 1000 | Oct 06, 1989 | Substantially Equivalent | Therapeutic Technologies, Inc. |
| K875317 | ELECTRICAL MUSCLE STIMULATOR MODEL MYOAID | Sep 08, 1989 | Substantially Equivalent | Electro Therapeutic Devices, Inc. |
| K881196 | AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL | Jun 16, 1989 | Substantially Equivalent | Biometer Intl. A/S |
| K884396 | MODIFIED THER-A-PULSE UNIT | May 18, 1989 | Substantially Equivalent | Westec Corp. |
| K890147 | RICH-MAR CONDUCTIVE GEL II W/ALOE VERA | Mar 23, 1989 | Substantially Equivalent | Rich-Mar Corp. |
| K881470 | SOKEN PLUS(TM) ELECTRONIC MUSCLE STIMULATOR | Mar 10, 1989 | Substantially Equivalent | Rehab Medical Specialties, Inc. |
| K874232 | MUSCLE STIM. DEVICES, BM 2000,4000,6000,8000 | Mar 10, 1989 | Substantially Equivalent | Health Systems Intl., Inc. |
| K874212 | VERIMED MYO/PREMS | Aug 08, 1988 | Substantially Equivalent | Verimed Holdings, Inc. |
| K880699 | ENDOMED CV405 | May 02, 1988 | Substantially Equivalent | Henley Intl. |
| K880948 | RICH-MAR G1000 EMS | Apr 21, 1988 | Substantially Equivalent | Rich-Mar Corp. |
| K881024 | ARCHGAUGE(TM) | Apr 08, 1988 | Substantially Equivalent | Archxerciser Corp. |
| K880235 | INTELECT MODEL 120 | Apr 08, 1988 | Substantially Equivalent | Chattanooga Group, Inc. |
| K881082 | GV 11 (TM), MODEL 9700 | Mar 28, 1988 | Substantially Equivalent | Medical Devices, Inc. |
| K875238 | SIEMENS NEUROTON 826 AND 827 | Mar 10, 1988 | Substantially Equivalent | Elmed, Inc. |
| K880234 | INTELECT VMS 2, OR INTELECT VMS II | Feb 24, 1988 | Substantially Equivalent | Chattanooga Group, Inc. |
| K874736 | RICH-MAR HV-2000 ELECTRICAL MUSCLE STIMULATOR | Jan 22, 1988 | Substantially Equivalent | Rich-Mar Corp. |
| K871421 | MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT | Jan 22, 1988 | Substantially Equivalent | Futuremed Div. of Future Impex Corp. |
| K874076 | MODIFIED OMNISTIM(TM) ELECTRICAL MUSCLE STIMULATOR | Jan 04, 1988 | Substantially Equivalent | Physio Technology, Inc. |
| K873125 | SOKEN(TM) ELECTRONIC MUSCLE STIMULATOR | Dec 31, 1987 | Substantially Equivalent | Rehab Medical Specialties, Inc. |
| K872606 | TELESONIC BODY STIMULATOR | Dec 22, 1987 | Substantially Equivalent | Telesonic, Inc. |
| K872974 | DYNATRAC | Nov 23, 1987 | Substantially Equivalent | Med*Ex Diagnostics of Canada, Inc. |
| K872970 | THER-A-PULSE | Nov 23, 1987 | Substantially Equivalent | Westec Corp. |
| K872036 | RICH-MAR CONDUCTIVE GEL | Nov 17, 1987 | Substantially Equivalent | Rich-Mar Corp. |
| K872655 | INTELECT 775 | Nov 03, 1987 | Substantially Equivalent | Chattanooga Group, Inc. |
| K872208 | MS-112, POWERED MUSCLE STIMULATOR | Oct 06, 1987 | Substantially Equivalent | Electro Med Supply, Inc. |
| K872207 | MS-108, POWERED MUSCLE STIMULATOR | Oct 06, 1987 | Substantially Equivalent | Electro Med Supply, Inc. |
| K872206 | MD-104, POWERED MUSCLE STIMULATOR | Oct 06, 1987 | Substantially Equivalent | Electro Med Supply, Inc. |
| K872753 | MYOSTIM(TM), MODEL 6600 | Oct 01, 1987 | Substantially Equivalent | Medical Devices, Inc. |
| K872654 | INTELECT MODEL 575 | Sep 24, 1987 | Substantially Equivalent | Chattanooga Group, Inc. |
| K870947 | DYNATRON 500 | Aug 18, 1987 | Substantially Equivalent | Dynatronics Corp. |
| K871472 | KINESTIM MUSCLE STIMULATOR | Jun 29, 1987 | Substantially Equivalent for Some Indications | Promatek Industries, Ltd. |
| K870515 | DYNATRON 438 | Jun 16, 1987 | Substantially Equivalent | Henley Intl. |
| K870774 | TRU-STIM MUSCLE STIMULATOR | Mar 18, 1987 | Substantially Equivalent | Briefcase, Inc. |
| K865070 | CHIRO-STIM | Mar 04, 1987 | Substantially Equivalent for Some Indications | Diversified Chiropractic Systems |
| K865054 | STIMUTRON MODEL 100 | Feb 26, 1987 | Substantially Equivalent for Some Indications | The Austin-Lenick Co. |
| K864625 | MYOPAC (TM), MODEL 9600 | Dec 29, 1986 | Substantially Equivalent for Some Indications | Medical Devices, Inc. |
| K864558 | U66 EMS | Dec 29, 1986 | Substantially Equivalent for Some Indications | Suntec Health & Fitness Group, Inc. |
| K864284 | MUSCLE MASTER (MEDIUM VOLTAGE STIMULATOR) | Dec 29, 1986 | Substantially Equivalent for Some Indications | Modern Systems Technology, Inc. |
| K864010 | EMPI MODEL 712, LOGIX(TM), NMS | Dec 02, 1986 | Substantially Equivalent | Empi |
| K862685 | MUSCLE MASTER (BIPOLAR STIMULATOR) | Nov 25, 1986 | Substantially Equivalent | Modern Systems Technology, Inc. |
| K862487 | MS-139 ELECTRONIC MUSCLE STIMULATOR | Jul 16, 1986 | Substantially Equivalent for Some Indications | Electro Med Supply, Inc. |
| K862486 | MS-159 ELECTRONIC MUSCLE STIMULATOR | Jul 16, 1986 | Substantially Equivalent for Some Indications | Electro Med Supply, Inc. |
| K862485 | MS-179 ELECTRONIC MUSCLE STIMULATOR | Jul 16, 1986 | Substantially Equivalent for Some Indications | Electro Med Supply, Inc. |
| K862031 | HAWKINS MINI-E.B.A. | Jul 14, 1986 | Substantially Equivalent for Some Indications | Pb Sales C/O Geller & Bozeman |
| K861136 | INTERSTIM 100 SYSTEM | Jul 09, 1986 | Substantially Equivalent for Some Indications | Buckman Co., Inc. |
| K861796 | FITTRONIC | Jun 25, 1986 | Substantially Equivalent | Corleone Intl. Traders, Inc. |
| K860315 | NEUROTECH-16 PROGRAM SYSTEM CONTROLLER MODEL 280 | Jun 17, 1986 | Substantially Equivalent | Neurotech, Inc. |
| K860314 | NEUROTECH-4 PROGRAM NEUROMUSCULAR STIMULATOR 281 | Jun 17, 1986 | Substantially Equivalent | Neurotech, Inc. |
| K854485 | RICH-MAR IF 200 | Jun 10, 1986 | Substantially Equivalent | Rich-Mar Corp. |
| K861739 | TEC PORTAMAX H.V. PULSED GALVANIC STIMULATOR | Jun 09, 1986 | Substantially Equivalent | J.A. Preston Corp. |
| K860619 | ES 180-DCM MUSCLE STIMULATOR | May 30, 1986 | Substantially Equivalent | Promatek |
| K860758 | VACO SUCTION ELECTRODE UNIT | May 02, 1986 | Substantially Equivalent | Zimmer Elektromedizin GmbH |
| K860107 | SYS*STIM 206 (MODEL-ME 206) | Mar 28, 1986 | Substantially Equivalent for Some Indications | Mettler Electronics Corp. |
| K855249 | MIDIFICATION SYS*STIM 207 (MODEL-ME207) | Mar 28, 1986 | Substantially Equivalent for Some Indications | Mettler Electronics Corp. |
| K853154 | HV-4 | Mar 28, 1986 | Substantially Equivalent for Some Indications | Robert Bosch Corp. |
| K854801 | MS-189 MUSCLE STIMULATOR | Mar 27, 1986 | Substantially Equivalent | Electro Med Supply, Inc. |
| K854720 | NEMECTRODYN MODEL 2 & ENDOVAC 2 POWER MUSCLE STIM. | Mar 10, 1986 | Substantially Equivalent | Nemectron Medical, Inc. |
| K854775 | EMPI MODEL 730 NMS | Feb 12, 1986 | Substantially Equivalent for Some Indications | Empi |
| K854774 | EMPI MODEL 720 NMS | Feb 12, 1986 | Substantially Equivalent for Some Indications | Empi |
| K853750 | SYS*STIM 207 MODEL ME 207 | Nov 26, 1985 | Substantially Equivalent for Some Indications | Mettler Electronics Corp. |
| K852077 | VERSA STIM 380, MUSCLE STIMULATOR | Aug 21, 1985 | Substantially Equivalent for Some Indications | Electro-Med Health Industries, Inc. |
| K844727 | MODEL 1000 | Jul 09, 1985 | Substantially Equivalent for Some Indications | Verite |
| K851046 | MYOCARE PLUS DUAL CHANNEL STIMULATOR | Jul 01, 1985 | Substantially Equivalent for Some Indications | 3M Company |
| K850850 | AUTOMOVE/OMNISTIM IV-ELECTRICAL MUSCLE STIMULATOR | Jul 01, 1985 | Substantially Equivalent for Some Indications | Physio Technology, Inc. |
| K844126 | SONTEC II | Jul 01, 1985 | Substantially Equivalent for Some Indications | Sontec, Inc. |
| K851037 | ORTHOTRON MUSCLE STIMULATOR MK II DC | Jun 19, 1985 | Substantially Equivalent for Some Indications | Hodgkinson & Corby , Ltd. |
| K850698 | MEDIUM FREQU. ELEC. MUSCLE STIMULATOR | May 17, 1985 | Substantially Equivalent | Chattanooga Group, Inc. |
| K850453 | SINUS AC-POWERED MUSCLE STIMULATOR | May 07, 1985 | Substantially Equivalent | Zimmer Elektromedizin GmbH |
| K844390 | ESCOTEK-EST 204 MULTI STIM | May 07, 1985 | Substantially Equivalent | Nor-Am Patient Care Products, Inc. |
| K844389 | ESCOTEK EST 210, HIGH VOLTAGE ELECTRO GALVANIC STI | May 07, 1985 | Substantially Equivalent | Nor-Am Patient Care Products, Inc. |
| K844388 | ESCOTEK EST 220 INTERFERENCE THERAPY UNIT | May 07, 1985 | Substantially Equivalent | Nor-Am Patient Care Products, Inc. |
| K844387 | ESCOTEK-EST 221 VACUUM UNIT | May 07, 1985 | Substantially Equivalent | Nor-Am Patient Care Products, Inc. |
| K850013 | SYS STIM 206(MODEL-ME 206) MUSCLE STIMULATOR | Apr 08, 1985 | Substantially Equivalent | Mettler Electronics Corp. |
| K850047 | SANYO ELECTRONIC MUSCLE STIMULATORS | Mar 05, 1985 | Substantially Equivalent | General Physiotherapy, Inc. |
| K844617 | EXCEL TECH MST-7 ISOELECTRONIC THERAPY DEVICE | Mar 05, 1985 | Substantially Equivalent | Excel Tech. , Ltd. |
| K844489 | ELECTRONIC MUSCLE STIMULATOR | Mar 05, 1985 | Substantially Equivalent | Beverly Hills Exercise Equipment |
| K844580 | MEDCOLATOR MODEL HVX | Feb 25, 1985 | Substantially Equivalent | Medco Products, Co., Inc. |
| K844466 | THE PROBE 100 | Feb 21, 1985 | Substantially Equivalent | Rich-Mar Corp. |
| K833928 | MYOPULSE | Dec 14, 1984 | Substantially Equivalent | Biomedical Design Instruments |
| K843583 | FIRM-A-TRON MARK X | Nov 29, 1984 | Substantially Equivalent | Biotron , Ltd. |
| K843638 | HEALTH PULSE FA-222 POWER MUSCLE STIMUL | Nov 23, 1984 | Substantially Equivalent | Therapeutic Equipment Corp. |
| K843488 | ELECTROSTIM 380 | Sep 19, 1984 | Substantially Equivalent | Micron Instruments, Inc. |
| K842712 | MEDCOLATOR MODEL GX | Sep 19, 1984 | Substantially Equivalent | Medco Products, Co., Inc. |
| K842804 | DIADYN 4 | Aug 21, 1984 | Substantially Equivalent | Robert Bosch Corp. |
| K842803 | INTERFERENZ 4 | Aug 21, 1984 | Substantially Equivalent | Robert Bosch Corp. |
| K842268 | VACUPULSE VACUUM UNIT | Jul 20, 1984 | Substantially Equivalent | I-Rep, Inc. |
| K841647 | NEUROMEDICS ULTRASTIM 650-01 | Jul 03, 1984 | Substantially Equivalent | Intermedics, Inc. |
| K842142 | BX-400 | Jun 25, 1984 | Substantially Equivalent | Bloomex International, Inc. |
| K841779 | ELECTRONIC MUSCLE EXERCISE EQUIPMENT | May 30, 1984 | Substantially Equivalent | Bloomex International, Inc. |
| K841579 | MULTIPLEX I, INTERFERENTIAL CURRENT | May 10, 1984 | Substantially Equivalent | Houwers Enterprises , Ltd. |
| K841382 | EMPI MODEL 712, LOGIX, NMS | May 07, 1984 | Substantially Equivalent | Empi |
| K841278 | OMNISTIM III INTERFERENTIAL THERAPY | Apr 24, 1984 | Substantially Equivalent | Physio Technology, Inc. |
| K840895 | ELECTRICAL NEURO-MUSCULAR STIMULATOR | Apr 24, 1984 | Substantially Equivalent | Richards Medical Co., Inc. |
| K841112 | TTI REHABILATATION GYM SYS | Apr 04, 1984 | Substantially Equivalent | Therapeutic Technologies, Inc. |
| K840724 | MUSCLE STIMULATOR X-10 | Mar 05, 1984 | Substantially Equivalent | Biostim, Inc. |
| K840467 | NEUROMUSCULAR STIMULATOR 3105 | Feb 17, 1984 | Substantially Equivalent | Medtronic Vascular |
| K840346 | NEUROMUSCLAR II | Feb 10, 1984 | Substantially Equivalent | Mentor Corp. |
| K840149 | BMR POWERSTIM | Jan 30, 1984 | Substantially Equivalent | Bio-Medical Research Corp. |
| K840148 | BMR-16 CLINIC MUSCLE STIMULATOR | Jan 30, 1984 | Substantially Equivalent | Bio-Medical Research Corp. |
| K840147 | BMR-2 MUSCLE STIMULATOR | Jan 30, 1984 | Substantially Equivalent | Bio-Medical Research Corp. |
| K833945 | COSMODYN-S INTERFERENTIAL MUSCLE STIM | Dec 23, 1983 | Substantially Equivalent | Leo Unlimited, Inc. |
| K832805 | BIONICARE STIMULATOR BIO-1 | Dec 23, 1983 | Substantially Equivalent | Murray Electronics |
| K834092 | MULTIPLE SOKEN 3 ELECTRON-MUSCLE STIM | Dec 20, 1983 | Substantially Equivalent | Rehab Medical Specialties, Inc. |
| K833808 | NUTRA-TONE 500 | Dec 12, 1983 | Substantially Equivalent | Applied Optic Kinetics , Ltd. |
| K832976 | BX-600 EMS | Nov 25, 1983 | Substantially Equivalent | Bloomex International, Inc. |
| K832988 | STAODYN EMS/PLUS | Nov 22, 1983 | Substantially Equivalent | Staodynamics, Inc. |
| K832546 | MARK V HIGH VOLTAGE GALVANIC STIMULATORR | Oct 14, 1983 | Substantially Equivalent | Orthion Corp. |
| K831473 | ULTRA PULSATOR MF | Jul 26, 1983 | Substantially Equivalent | Medelco , Ltd. |
| K831003 | MEASURE-UP MUSCLE STIMULATOR | Jun 20, 1983 | Substantially Equivalent | Measure-Up Intl., Inc. |
| K830055 | RICH-MAR HV 20 | Mar 10, 1983 | Substantially Equivalent | Rich-Mar Corp. |
| K822924 | MINISTIM 180 | Dec 13, 1982 | Substantially Equivalent | Micron Instruments, Inc. |
| K823279 | RESPOND QUADRIFLEX #3129 SINGLE CHANNEL | Nov 22, 1982 | Substantially Equivalent | Medtronic Vascular |
| K822519 | HAWKINS EBA -16 MUSCLE STIMULATOR | Oct 13, 1982 | Substantially Equivalent | A-Zenith Therapeutic Equipment/Supply |
| K822287 | BX-500 ELECTRONIC MUSCLE EXERCISER | Oct 13, 1982 | Substantially Equivalent | Bloomex International, Inc. |
| K822056 | EXER-STIM CONTROLLER | Oct 06, 1982 | Substantially Equivalent | Th Charters, Inc. |
| K822250 | MYO-TONE, INC. SYSTEM-80 | Sep 22, 1982 | Substantially Equivalent | Myo-Tone, Inc. |
| K822284 | COMPLY NEUROMUSCULAR STIMULATOR | Sep 17, 1982 | Substantially Equivalent | Omega-Med Intl., Inc. |
| K821449 | P6S ATHLETIC | Jul 22, 1982 | Substantially Equivalent | Squire, Sanders & Dempsey |
| K820953 | EF2000 | Jul 22, 1982 | Substantially Equivalent | Squire, Sanders & Dempsey |
| K821110 | ELECTRONIC MUSCLE EXERCISER | Jul 01, 1982 | Substantially Equivalent | Bloomex International, Inc. |
| K820080 | BX-1000 ISOMATIC | Jul 01, 1982 | Substantially Equivalent | Bloomex International, Inc. |
| K821157 | HETERODYNAMIC | Jun 23, 1982 | Substantially Equivalent | Birtcher Corp. |
| K820938 | HAWKINS ELECTROKINETIC BODY ACTIVATING | Jun 11, 1982 | Substantially Equivalent | Leisure Way |
| K820782 | THERATRONIC STIMULATOR | Jun 03, 1982 | Substantially Equivalent | Theratronics, Inc. |
| K820884 | ELECTRICAL MUSCLE STIMULATOR | Apr 29, 1982 | Substantially Equivalent | Nitron Electronics |
| K820784 | CLINIC 2000 MODEL MULTI-FRECODYN DEVICE | Apr 22, 1982 | Substantially Equivalent | Dimeco |
| K813604 | OMNI STIM II | Mar 08, 1982 | Substantially Equivalent | Omni Intl., Inc. |
| K813443 | BX-400 SPORT | Mar 08, 1982 | Substantially Equivalent | Bloomex International, Inc. |
| K813410 | BX-400 JESSE JIMBODY | Mar 08, 1982 | Substantially Equivalent | Bloomex International, Inc. |
| K813533 | ELECTRIC MUSCLE STIMULATOR | Mar 05, 1982 | Substantially Equivalent | Myo-Tronics Research, Inc. |
| K820168 | MENTOR ACTIVATOR NEUROMUSCULAR STIMU | Feb 24, 1982 | Substantially Equivalent | Mentor Corp. |
| K813181 | ELECTROC-GYM | Feb 19, 1982 | Substantially Equivalent | Electrola |
| K813108 | MODEL 500 VERI/500 | Feb 19, 1982 | Substantially Equivalent | Verite |
| K813456 | HIGH VOLTAGE GALVANIC STIMULATOR 550 | Jan 29, 1982 | Substantially Equivalent | Chattanooga Group, Inc. |
| K812984 | SLIMTRONICS 2000 | Jan 19, 1982 | Substantially Equivalent | Ems Dist. |
| K812851 | SBP-16 CLINIC MUSCLE STIMULATOR | Dec 29, 1981 | Substantially Equivalent | Southwestern Bio-Physical Corp. |
| K813008 | RESPOND II...NEUROMUSCULAR STIMULATOR | Dec 02, 1981 | Substantially Equivalent | Medtronic Vascular |
| K812538 | ELITE | Dec 01, 1981 | Substantially Equivalent | Biotone International, Inc. |
| K811737 | BIO-TONE MODEL 4 | Oct 14, 1981 | Substantially Equivalent | Biotone International, Inc. |
| K811395 | EMPI MODEL 710, NMS | Aug 24, 1981 | Substantially Equivalent | Empi |
| K811502 | STIMULATOR, FACIAL-MODELS SF-100 & 200 | Jul 24, 1981 | Substantially Equivalent | Rcx-Western, Inc. |
| K811250 | ELECTRONIC MUSCLE STIMULATOR | Jul 24, 1981 | Substantially Equivalent | Electrola |
| K810975 | MINITONE | Jun 12, 1981 | Substantially Equivalent | Bloomex International, Inc. |
| K810634 | FIRM-A-TRON | Jun 12, 1981 | Substantially Equivalent | Biotron , Ltd. |
| K810513 | ELECTRODYN CII-INTERFERENTIAL MUSCLE | May 11, 1981 | Substantially Equivalent | Nemectron Medical, Inc. |
| K810225 | LITRONIC STIMULATOR | Mar 30, 1981 | Substantially Equivalent | Med-Western Electronics, Inc. |
| K810246 | ELITE | Mar 16, 1981 | Substantially Equivalent | Bloomex International, Inc. |
| K802804 | NEMECTRODYN 8 | Mar 16, 1981 | Substantially Equivalent | Nemectron Medical, Inc. |
| K810496 | VERI/PMS MODEL 815 | Mar 13, 1981 | Substantially Equivalent | Verite |
| K810247 | MBI-4 | Mar 10, 1981 | Substantially Equivalent | Bloomex International, Inc. |
| K803314 | SKIN BEAUTY CLEANSER & TONER | Mar 06, 1981 | Substantially Equivalent | Dynex International, Ltd. |
| K810044 | MUSCLE STIMULATOR | Feb 26, 1981 | Substantially Equivalent | Micron Instruments, Inc. |
| K810064 | PULSARII, HIGH VOLT. GALVANIC MUSC. STIM | Jan 26, 1981 | Substantially Equivalent | Bomed Medical Mfr., Ltd. |
| K810057 | GALVANATOR 725 | Jan 23, 1981 | Substantially Equivalent | Avratronics Corp. |
| K803064 | ZIMMER ELECTRICAL MUSCLE STIMULATOR | Dec 31, 1980 | Substantially Equivalent | Zimmer, Inc. |
| K802269 | FIGURETRIM | Oct 13, 1980 | Substantially Equivalent | Colne Medical Co. , Ltd. |
| K802107 | EGS #300 BATTERY OPER. PORTA. MUSCLE STI | Oct 03, 1980 | Substantially Equivalent | Electro-Med Health Industries, Inc. |
| K801577 | NEUROGAR IV-EXTERNAL NEURO-MUSCLE STIM. | Aug 27, 1980 | Substantially Equivalent | Inter Med Industries, Inc. |
| K801790 | INTELECT | Aug 20, 1980 | Substantially Equivalent | Chattanooga Group, Inc. |
| K801053 | PULSED GALVANIC STIMULATOR, 450-DYNAMAX | Jun 04, 1980 | Substantially Equivalent | U.S. Medical Corp. |
| K800484 | MOD. 3127 NEUROMUSCULAR STIMULATOR | May 02, 1980 | Substantially Equivalent | Medtronic Vascular |
| K800486 | STIM-EX 201 | Mar 19, 1980 | Substantially Equivalent | Th Charters, Inc. |
| K800068 | ELECTRICAL MUSCLE STIMULATOR (EMS) | Feb 05, 1980 | Substantially Equivalent | Staodynamics, Inc. |
| K791087 | PORTABLE PULSE GALVANIC STIMULATOR | Oct 12, 1979 | Substantially Equivalent | Staodynamics, Inc. |
| K791048 | STIMTECH NEUROMUSCULAR STIMULATOR, C 600 | Jul 03, 1979 | Substantially Equivalent | Stimulation Technology, Inc. |
| K790847 | EGS MODEL 300 | May 25, 1979 | Substantially Equivalent | Alfred V. Greco |
| K790120 | SLENDERTONE | May 07, 1979 | Substantially Equivalent | Bloomex International, Inc. |
| K790033 | HVG-100 | Feb 09, 1979 | Substantially Equivalent | Elmed, Inc. |
| K781239 | MYO-STIM | Nov 03, 1978 | Substantially Equivalent | Med General |
| K781319 | THERAPY APPAR. 422 INTERFERENTIAL | Oct 03, 1978 | Substantially Equivalent | General Theraphysical, Inc. |
| K781318 | DYNATRON 406 ELECTROTHERAPY APPARATUS | Oct 03, 1978 | Substantially Equivalent | General Theraphysical, Inc. |
| K781315 | MUSCLE STIMULATION APPARATUS | Oct 03, 1978 | Substantially Equivalent | General Theraphysical, Inc. |
| K781139 | MUSCLE STIMULATOR, ELECTRONIC | Sep 26, 1978 | Substantially Equivalent | Thor Medical Instruments, Inc. |
| K781113 | MUSCLE STIMULATOR, ELECTRICAL | Sep 26, 1978 | Substantially Equivalent | Rich-Mar Corp. |
| K781167 | STEMPLEX | Sep 15, 1978 | Substantially Equivalent | Rich-Mar Corp. |
| K781080 | GALVANATOR, MODEL 770 | Jul 07, 1978 | Substantially Equivalent | Avra Corp. |
| K780133 | MUSCLE STIMULATOR, ELECTRICAL | Feb 02, 1978 | Substantially Equivalent | De Electronics |
| K770276 | ELECTROTHERAPY APPARATUS E.T. 720 | Mar 09, 1977 | Substantially Equivalent | Fort & Assoc. |
| K760462 | ELECTRICAL SHOCK DEVICE | Mar 01, 1977 | Substantially Equivalent | Edward V. Kaufholz, Sr. |
| K760547 | STIMULATOR, ELECTRICAL MUSCLE (#MD-4) | Feb 17, 1977 | Substantially Equivalent | R. A. Fischer Co. Corp. |
| K761220 | TECA MODEL SP5/T ELECTRO-THER. STIM. | Dec 17, 1976 | Substantially Equivalent | Teca, Inc. |
| K760913 | MICROTYNE UNIT | Nov 12, 1976 | Substantially Equivalent | Transmed, Inc. |
| K760503 | STIMULATOR, ELECTRICAL MUSCLE (#MD-8) | Sep 27, 1976 | Substantially Equivalent | R. A. Fischer Co. Corp. |
FEI Numbers
This FDA classification entry is associated with 170 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 170 registration numbers. Click on an entry to view related FDA registrations.