Product Code: GZJ FDA class 2 21 CFR 882.5890

Stimulator, Nerve, Transcutaneous, For Pain Relief

Neurology

The Transcutaneous Nerve Stimulator for Pain Relief, commonly known as a TENS unit, is a non-invasive device that delivers low-voltage electrical currents through electrodes placed on the skin to modulate pain signals and provide relief from acute and chronic pain. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GZJ under regulation 21 CFR 882.5890 in the Neurology specialty. It is eligible for third-party 510(k) review.

View on FDA

510(k)s

606

FEI Numbers

184

Registration Numbers

184

Unique Applicants

324

Years Active

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Basic Information

Product Code: GZJ
Device Class: FDA class 2
Regulation Number: 882.5890
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 606 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252712	STIMPOD NMS460 Nerve Stimulator	May 28, 2026	Substantially Equivalent	Algiamed Technologies USA, Inc.
K252767	actiTENS mini	Jan 16, 2026	Substantially Equivalent	Sublimed
K252236	CP Relief Wand Rx - TENS/NMES	Aug 15, 2025	Substantially Equivalent	N & C Holdings, LLC
K232441	Unipro (K-UNIPRO-US)	Aug 30, 2024	Substantially Equivalent	Tenscare, Ltd.
K241228	TENSWave	Aug 27, 2024	Substantially Equivalent	Zynex Medical Officer
K233046	Electrical Neuromuscular Stimulator, Cure Trio	Apr 19, 2024	Substantially Equivalent	Oriental Inspiration Limited
K222879	Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)	Jan 24, 2023	Substantially Equivalent	Wuxi Jiajian Medical Instrument Co., Ltd.
K212618	iRelieve Microcurrent Pain Relief System	Sep 14, 2022	Substantially Equivalent	Fast Track Technologies, Inc.
K213802	StimOnTM Pain Relief System (GM2439)	Aug 26, 2022	Substantially Equivalent	Gimer Medical Co., Ltd.
K220578	Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)	May 25, 2022	Substantially Equivalent	Bozhou Rongjian Medical Appliance Co., Ltd.
K220503	TENS device-EmeTerm 2, Model: YF-ZTY-E2	Apr 23, 2022	Substantially Equivalent	Wat Medical Technology, Inc.
K202893	Transcutaneous Electrical Nerve Stimulator	Jun 18, 2021	Substantially Equivalent	Wuxi Jiajian Medical Instrument Co., Ltd.
K202186	TrueRelief Device	Mar 23, 2021	Substantially Equivalent	Truerelief
K210202	BioWaveGO RX	Feb 24, 2021	Substantially Equivalent	Biowave Corporation
K201458	Scrambler Therapy Technology (Model ST-5A)	Dec 23, 2020	Substantially Equivalent	Delta International Services & Logistics S.R.L
K202159	actiTENS	Dec 22, 2020	Substantially Equivalent	Sublimed
K201431	OGYILI TENS/NMES Stimulator	Nov 09, 2020	Substantially Equivalent	Gongguan Tutamen Metalwork Co., Ltd.
K181645	StimaWELL 120MTRS	Aug 13, 2020	Substantially Equivalent	Pierenkemper GmbH
K191547	ReliefBand	Aug 30, 2019	Substantially Equivalent	Reliefband Technologies, LLC
K182960	ReliefBand	Jun 21, 2019	Substantially Equivalent	Reliefband Technologies, LLC
K182025	ClearUP Sinus Pain Relief	Jan 02, 2019	Substantially Equivalent	Tivic Health Systems, Inc.
K180943	BioWaveGO	Aug 17, 2018	Substantially Equivalent	Biowave Corporation
K172478	TENS device-EmeTerm, CinvStop	Apr 19, 2018	Substantially Equivalent	Wat Medical Technology (Ningbo) Co., Ltd.
K173233	ReliefBand 1.5	Nov 30, 2017	Substantially Equivalent	Reliefband Technologies
K161091	STIMPOD NMS460 Nerve Stimulator	Jan 18, 2017	Substantially Equivalent	Xavant Technology (Pty), Ltd.
K162663	WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A	Jan 17, 2017	Substantially Equivalent	Well-Life Healthcare Limited
K160246	SimulCare II(TM)	Oct 06, 2016	Substantially Equivalent	Xanacare Technologies, LLC
K153704	Strive	Jun 03, 2016	Substantially Equivalent	Djo, LLC
K152676	FD TENS 2090, FD TENS 2095	Jan 22, 2016	Substantially Equivalent	Fuji Dynamics , Ltd.
K152437	BiowaveHOME Neuromodulation Pain Therapy Device	Sep 25, 2015	Substantially Equivalent	Biowave Corporation
K143198	Synapse Transcutaneous Electrical Stimulation Device	May 27, 2015	Substantially Equivalent	Synapse Electroceutical Limited
K142666	Scrambler Therapy MC-5 A Device	May 22, 2015	Substantially Equivalent	Delta International Services & Logistics S.R.L
K131513	SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY	Jul 11, 2014	Substantially Equivalent	Ritm Okb Zao
K133779	CP RELIEF WAND	May 30, 2014	Substantially Equivalent	Mid-America Medical Innovations, LLC
K123099	Best-AV2 Pro-Sport(tm)	May 23, 2014	Substantially Equivalent	Avazzia, Inc.
K131675	BODIHEALTH SYSTEM	Mar 12, 2014	Substantially Equivalent	Eprt Technologies, Inc.
K123958	JIAJIAN POINTOSELECT DIGITAL	Oct 28, 2013	Substantially Equivalent	Wuxi Jiajian Medical Instrument Co., Ltd.
K130919	SENSUS	Jul 02, 2013	Substantially Equivalent	Neurometrix, Inc.
K122948	GEM-STIM COMBO STIMULATOR	Dec 21, 2012	Substantially Equivalent	Gemore Technology Co, Ltd.
K121369	NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR	Dec 19, 2012	Substantially Equivalent	Ibramed Equipamentos Medicos
K121305	STERLING MEDICAL IMPULSE 3 STIMULATOR	Sep 25, 2012	Substantially Equivalent	Armstrong Industries, Inc. Dha Mediquip Int. Dha S
K120398	WITOUCH PRO	Aug 16, 2012	Substantially Equivalent	Hollywog, LLC
K121184	SENSUS	Aug 02, 2012	Substantially Equivalent	Neurometrix, Inc.
K121578	ATOM 1 (MODEL: BRC 2200)	Jul 31, 2012	Substantially Equivalent	Bioelectric Research Corporation
K113544	ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER	Jul 27, 2012	Substantially Equivalent	Prospera Corporation
K120569	GEMORE TENS SYSTEM	Jul 20, 2012	Substantially Equivalent	Gemore Technology Co, Ltd.
K120054	ULTIMA NEO	Jun 05, 2012	Substantially Equivalent	Pain Management Technologies
K112288	JIAJIAN TENS	May 02, 2012	Substantially Equivalent	Wuxi Jiajian Medical Instrument Co., Ltd.
K111654	FD TENS 2070	Mar 01, 2012	Substantially Equivalent	Fuji Dynamics , Ltd.
K112258	NEUROTECH PLUS	Jan 09, 2012	Substantially Equivalent	Bio-Medical Research, Ltd.
K112485	H-WAVE	Dec 06, 2011	Substantially Equivalent	Electronic Waveform Lab, Inc.
K111645	FD TENS 2050 OR SLIDE TENS MODEL FD2050	Nov 09, 2011	Substantially Equivalent	Fuji Dynamics , Ltd.
K102278	QUADRA BLOC TENS PLUS	Oct 20, 2011	Substantially Equivalent	Gradient Technologies, LLC
K110350	KNEEHAB XP	Aug 03, 2011	Substantially Equivalent	Bio-Medical Research, Ltd.
K110390	ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR	Jul 29, 2011	Substantially Equivalent	Handelshaus Dittman GmbH
K100668	NEMA-ST, MODEL V1.0.2	Dec 08, 2010	Substantially Equivalent	Nervomatrix, Ltd.
K102014	TENS STIMULATOR, MODELS 2800 AND 3000	Aug 31, 2010	Substantially Equivalent	Koalaty Products, Inc.
K100399	4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A	Jun 25, 2010	Substantially Equivalent	Well-Life Healthcare Limited
K092117	SCENAR, MODEL 10	May 28, 2010	Substantially Equivalent	Ritm Okb Zao
K092448	HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2	Mar 30, 2010	Substantially Equivalent	Hivox Biotek, Inc.
K091045	SMART TENS, MODEL: D-BC05T	Dec 18, 2009	Substantially Equivalent	Body Clock Health Care, Ltd.
K092990	AMD 6605 TENS/NMES	Oct 23, 2009	Substantially Equivalent	Advantageous Medical Devices, LLC
K090866	NEUROCALM MODEL 1 AND 2	Oct 21, 2009	Substantially Equivalent	Neuromed Devices, Inc.
K083250	NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS	Aug 18, 2009	Substantially Equivalent	Aa Neuromed Corp.
K091236	MANTRA COMBO, MODEL MECS 320	Jul 30, 2009	Substantially Equivalent	Mantra Intl. (Hk) , Ltd.
K091317	LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK	Jun 25, 2009	Substantially Equivalent	Bio-Medical Research, Ltd.
K090922	EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR	Jun 05, 2009	Substantially Equivalent	Empi
K090717	FLEX-TENS	May 08, 2009	Substantially Equivalent	Emsi
K083822	LASER TOUCHONE	May 06, 2009	Substantially Equivalent	Laser Health Technologies, LLC
K081835	ACTICARE IC AND TSE	Mar 19, 2009	Substantially Equivalent	Bioinduction Limited
K082190	BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298	Mar 11, 2009	Substantially Equivalent	Bio-Medical Research, Ltd.
K082057	DX6605E-TENS, DX6605E-G, DX6609-G	Feb 26, 2009	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.
K081255	SCRAMBLER ST 5 TENS DEVICE	Feb 20, 2009	Substantially Equivalent	Competitive Technologies,Inc.
K082377	TENSCARE ITOUCH MODEL(S) EASY AND PLUS	Feb 09, 2009	Substantially Equivalent	Tenscare, Ltd.
K083030	TENS-EMS-14	Feb 05, 2009	Substantially Equivalent	Emsi
K083494	ULTIMA FIVE	Jan 06, 2009	Substantially Equivalent	Pain Management Technologies
K083202	COMBOCARE 2000	Dec 15, 2008	Substantially Equivalent	Xanacare Technologies, LLC
K082011	MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458	Nov 28, 2008	Substantially Equivalent	Bio-Medical Research, Ltd.
K082514	TENS/EMS COMBO, EMS, TENS	Oct 21, 2008	Substantially Equivalent	Medihightec Medical Co., Ltd.
K080221	EA STIMULATOR	Sep 09, 2008	Substantially Equivalent	Helio Medical Supplies, Inc.
K081141	COMBOCARE 2000	Aug 29, 2008	Substantially Equivalent	Xanacare Technologies, LLC
K080304	PRO TENS, MODEL WL-240 RX	Jun 20, 2008	Substantially Equivalent	Well-Life Healthcare Limited
K071120	AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999	Mar 13, 2008	Substantially Equivalent	Aemed, Inc.
K073008	KFH ENERGY, MODEL: E1	Mar 11, 2008	Substantially Equivalent	Kingfisher Healthcare NV
K071869	TENS/IF 14	Mar 07, 2008	Substantially Equivalent	Emsi
K073438	PROSTIM 1000/2000	Feb 07, 2008	Substantially Equivalent	Bio Protech, Inc.
K072123	HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE	Feb 01, 2008	Substantially Equivalent	Biowave Corporation
K071878	DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB	Dec 07, 2007	Substantially Equivalent	Med-Lectric Corporation
K071624	EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR	Nov 27, 2007	Substantially Equivalent	Everlife Medical Equipment Co., Ltd.
K062003	NEURO WAVE 6	Sep 19, 2007	Substantially Equivalent	Lhasa Oms, Inc.
K071951	COMFY SERIES: EV-804, EV-805 & EV-806	Sep 05, 2007	Substantially Equivalent	Everyway Medical Instruments Co.,Ltd
K061828	LORENZ BIOTECH APTIVA, VERSION 2.13	Aug 24, 2007	Substantially Equivalent	Lorenz Biotech S.P.A.
K070299	EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)	Jul 16, 2007	Substantially Equivalent	Ezfit Technology, Inc.
K062616	WELLNESSPRO 2010	Jul 06, 2007	Substantially Equivalent	Intelsource Group, Inc.
K062641	BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1	Apr 30, 2007	Substantially Equivalent	Avazzia, Inc.
K070474	NEWLIFE SCIENCES LLC, MODEL TMR	Apr 25, 2007	Substantially Equivalent	Newlife Sciences, LLC
K062547	QUADRA BLOC TENS, MODEL 101	Mar 21, 2007	Substantially Equivalent	Gradient Technologies, LLC
K052836	BODIHEALTH SYSTEM	Feb 13, 2007	Substantially Equivalent	Usa Laser Therapeutics, Inc.
K061516	STAODYN MAX PRESET, MODEL 4470	Feb 06, 2007	Substantially Equivalent	Compex Technologies, Inc.
K061650	SELECT TENS, MODEL 4600S	Jan 22, 2007	Substantially Equivalent	Empi
K060669	MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, ST-300	Oct 13, 2006	Substantially Equivalent	Healthonics, Inc.
K061799	QUADRATENS, MODEL QT-42	Aug 28, 2006	Substantially Equivalent	Bio-Research Associates, Inc.
K061476	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1	Jul 26, 2006	Substantially Equivalent	Biomedical Life Systems, Inc.
K052711	EMJOI TENS DEVICE	Jun 23, 2006	Substantially Equivalent	Emjoi, Inc.
K060517	POINTER EXCEL	Jun 19, 2006	Substantially Equivalent	Lhasa Oms, Inc.
K060508	POINTER PLUS	Jun 19, 2006	Substantially Equivalent	Lhasa Oms, Inc.
K060246	INFREX	May 05, 2006	Substantially Equivalent	Johari Digital Healthcare , Ltd.
K050989	AWQ-104	Apr 06, 2006	Substantially Equivalent	Lhasa Oms, Inc.
K060368	INSPIRSTAR IS02 MICROCURRENT STIMULATOR	Mar 14, 2006	Substantially Equivalent	Inspirstar, Inc.
K053284	MAGBODY DT-600	Mar 10, 2006	Substantially Equivalent	Durtech System Corp.
K051128	ELECTROPULSE	Mar 10, 2006	Substantially Equivalent	Pain Relief Technologies
K051020	ES-160	Feb 24, 2006	Substantially Equivalent	Lhasa Oms, Inc.
K052813	FD TENS 2030, MODEL DFJ24T	Jan 25, 2006	Substantially Equivalent	Fuji Dynamics Limited
K052182	SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S.	Nov 04, 2005	Substantially Equivalent	Shian Jia Meei Enterprise Co., Ltd.
K050174	BIO-STIM KIT	Sep 07, 2005	Substantially Equivalent	Skylark Device & Systems Co., Ltd.
K050435	E-STIM II	Sep 06, 2005	Substantially Equivalent	Lhasa Oms, Inc.
K042912	INTERX5000	May 17, 2005	Substantially Equivalent	Neuro Resource Group, Inc.
K050740	MICROWARE 200	Apr 06, 2005	Substantially Equivalent	Microware, Inc.
K042711	MODEL BMLS03-7	Mar 14, 2005	Substantially Equivalent	Biomedical Life Systems, Inc.
K042107	TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001	Mar 09, 2005	Substantially Equivalent	Tung FU Electric Co., Ltd.
K041388	COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1	Nov 23, 2004	Substantially Equivalent	Biomedical Life Systems, Inc.
K041172	BASBA E-MACHINE	Nov 18, 2004	Substantially Equivalent	Basba, Inc.
K042559	GEM-TWIN TENS/ MODELS GM3XY/Z	Nov 17, 2004	Substantially Equivalent	Gemore Technology Co, Ltd.
K040311	SHIAN JIA MEEI DIGATAL PWN TENS, MODEL YW-6000/UC-332/UC-330/ST-331	Oct 01, 2004	Substantially Equivalent	Shian Jia Meei Enterprise Co., Ltd.
K041520	MANTRA TENS MODEL NT3	Sep 03, 2004	Substantially Equivalent	Mantra Intl. (Hk) , Ltd.
K041359	BODY CLOCK STIMPLUS AND STIMPLUS PRO	Aug 20, 2004	Substantially Equivalent	Body Clock Health Care, Ltd.
K041575	FENZIAN TREATMENT SYSTEM	Jul 16, 2004	Substantially Equivalent	Eumedic Limited
K041092	FAST START TENS, MODEL FS 3001	Jul 01, 2004	Substantially Equivalent	Vision Quest Industries, Inc.
K040512	LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401	May 27, 2004	Substantially Equivalent	Well-Life Healthcare, Inc.
K041164	L-TENS	May 20, 2004	Substantially Equivalent	Fuji Dynamics Limited
K040193	MODEL GST-1	Apr 27, 2004	Substantially Equivalent	Medical Equipment Device Specialists
K023916	BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294	Apr 15, 2004	Substantially Equivalent	Bio-Medical Research, Ltd.
K040253	EASY MED TN-28 C	Apr 08, 2004	Substantially Equivalent	Easy Med Instrument Co., Ltd.
K033455	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5	Jan 15, 2004	Substantially Equivalent	Biomedical Life Systems, Inc.
K032003	PREMIER PLUS	Jan 07, 2004	Substantially Equivalent	American Imex
K033857	T-TECH DIGITAL, MODEL WL-22XXA SERIES	Dec 19, 2003	Substantially Equivalent	Well-Life Healthcare, Inc.
K032928	MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 1	Dec 19, 2003	Substantially Equivalent	Mediphysics Pain Centers of America
K032994	GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)	Dec 16, 2003	Substantially Equivalent	Gemore Technology Co, Ltd.
K032720	GEM-STIM TENS, MODELS GM3XY AND GM3AXY	Dec 10, 2003	Substantially Equivalent	Gemore Technology Co, Ltd.
K031374	BESMED VARIOUS MODELS OF TENS, BE-550/BE-660	Nov 28, 2003	Substantially Equivalent	Besmed Health Business Corp
K031546	RAINBOW GT-4A PAIN RELIEF MACHINE	Nov 13, 2003	Substantially Equivalent	Sino-Us Information, Inc.
K033253	S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR	Oct 21, 2003	Substantially Equivalent	Micro Current Technology, Inc.
K032055	MEDS-4-INF+	Oct 03, 2003	Substantially Equivalent	Medical Equipment Device Specialists
K032653	E275	Sep 12, 2003	Substantially Equivalent	Micro Current Technology, Inc.
K023913	NEUROTECH BAXOLVE TYPE 294	Aug 25, 2003	Substantially Equivalent	Bio-Medical Research, Ltd.
K023726	TENS PRO 900	Jun 17, 2003	Substantially Equivalent	Acumed Medical Supplies , Ltd.
K022849	BODY CLOCK TENS N' TONE	May 20, 2003	Substantially Equivalent	Body Clock Health Care, Ltd.
K021952	HIVOX DREAMATE DM-800	May 02, 2003	Substantially Equivalent	Hivox Biotek, Inc.
K022417	CARE STIM	Apr 10, 2003	Substantially Equivalent	Care Rehab and Orthopaedic
K023231	ELFCARE DEVICE, MODELS 314A THROUGH 314G	Apr 04, 2003	Substantially Equivalent	Mediseb , Ltd.
K030537	DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B	Mar 20, 2003	Substantially Equivalent	Well-Life Healthcare, Inc.
K030140	DUOMED, SERIES 500, (MODELS ID 500, FL 500)	Mar 18, 2003	Substantially Equivalent	Duomed, Inc.
K021271	ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-3	Feb 06, 2003	Substantially Equivalent	Biomedical Life Systems
K021270	ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-2	Feb 06, 2003	Substantially Equivalent	Biomedical Life Systems
K023443	MEDS-3 NEUROMUSCULAR STIMULATOR	Jan 13, 2003	Substantially Equivalent	Medical Equipment Device Specialists
K023435	MEDS-4 NEUROMUSCULAR STIMULATOR	Jan 13, 2003	Substantially Equivalent	Medical Equipment Device Specialists
K021794	TATUNG TMD-26AX SERIES TENS, MODELS NO. TMD-26AB TATUNG TENS (BLUE HOUSING) TMD-26AY TATUNG TENS (YELLOW HOUSING)	Jan 13, 2003	Substantially Equivalent	Tatung Co.
K020020	THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302)	Dec 30, 2002	Substantially Equivalent	Well-Life Healthcare, Inc.
K021430	SANIDAD TENS-DUO MODE GP8016N	Dec 02, 2002	Substantially Equivalent	Rolor Electronics Corp.
K021846	804SIII; 804W; LIBRA TENS; 410; S-TENS II	Nov 22, 2002	Substantially Equivalent	Body Clock Health Care, Ltd.
K022925	ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10	Nov 19, 2002	Substantially Equivalent	Biomedical Life Systems, Inc.
K022841	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9	Nov 19, 2002	Substantially Equivalent	Biomedical Life Systems, Inc.
K022731	V TENS PLUS	Nov 14, 2002	Substantially Equivalent	Body Clock Health Care, Ltd.
K020749	DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS	Oct 31, 2002	Substantially Equivalent	Everyway Medical Instruments Co.,Ltd
K022076	FIRST CHOICE & FIRST CHOICE PLUS	Sep 24, 2002	Substantially Equivalent	Body Clock Health Care, Ltd.
K020712	ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4	Sep 24, 2002	Substantially Equivalent	Biomedical Life Systems, Inc.
K013532	ULTRASTIM KIT	Aug 22, 2002	Substantially Equivalent	Axelgaard Mfg. Co., Ltd.
K022405	MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC	Aug 12, 2002	Substantially Equivalent	Rehabilicare, Inc.
K021496	HMS-DHR-3 NEUROMUSCULAR STIMULATOR	Aug 06, 2002	Substantially Equivalent	Home Medical Services
K021436	TTECH MODEL 200E + TENS DEVICE	Jul 30, 2002	Substantially Equivalent	Theratech, Inc.
K011891	PANAG	Jul 30, 2002	Substantially Equivalent	Panag International
K014020	NT MEDITENS PLUS, TYPE 290	Jul 11, 2002	Substantially Equivalent	Bio-Medical Research, Ltd.
K021755	APEX MEDICAL DIGITAL TENS TS1211, TS1212	Jun 12, 2002	Substantially Equivalent	Apex Medical Corp.
K020803	CEFAR MEDICAL AB CEFAR PRIMO	Jun 10, 2002	Substantially Equivalent	Cefar Medical AB
K020846	ULTIMA TENS XL-A1	May 21, 2002	Substantially Equivalent	Tenscare, Ltd.
K014126	SANIDAD HEALTH-UP TENS MP-73725	May 03, 2002	Substantially Equivalent	Roc Chinese-European Industrial Research Society
K021359	DIGI-PRO TENS MODEL WL-2203 AND WL-2205	Apr 30, 2002	Substantially Equivalent	Well-Life Healthcare, Inc.
K013210	TRUWAVE	Apr 04, 2002	Substantially Equivalent	Dan Med, Inc.
K020180	RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL	Mar 21, 2002	Substantially Equivalent	Woodside Biomedical, Inc.
K020437	CLASSIC TENS	Mar 15, 2002	Substantially Equivalent	Care Rehab, Inc.
K003744	ENRAF-NONIUS ENDOMED 182 SYSTEM	Feb 20, 2002	Substantially Equivalent	Henley Healthcare, Inc.
K020032	APEX MEDICAL MINI TENS	Jan 31, 2002	Substantially Equivalent	Apex Medical Corp.
K013167	MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500	Jan 30, 2002	Substantially Equivalent	Newcare Products, LLC
K013507	COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH	Jan 25, 2002	Substantially Equivalent	Cosmo Health, Inc.
K004008	STRESS GUARD, MODEL HERDEV1	Dec 13, 2001	Substantially Equivalent	Herbo Medex International, Inc.
K012643	APEX MEDICAL LCD TENS-VII	Oct 29, 2001	Substantially Equivalent	Apex Medical Corp.
K012848	WINNER CM4 COMBINATION UNIT	Oct 25, 2001	Substantially Equivalent	Rich-Mar Corp.
K010615	CYCLOTEC AMT CTI TENS DEVICE	Oct 12, 2001	Substantially Equivalent	Cyclotec
K011017	PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT	Sep 24, 2001	Substantially Equivalent	Rehabilicare, Inc.
K011543	TENS CARE, MODEL XL-Y3	Aug 31, 2001	Substantially Equivalent	Tenscare, Ltd.
K010203	ACCU-PULSE TENS UNIT	Aug 28, 2001	Substantially Equivalent	Sadler Electronics
K010295	MICROSTIM 100I TENS DEVICE	Aug 03, 2001	Substantially Equivalent	Microstim, Inc.
K002874	WELL-TENS	Jul 27, 2001	Substantially Equivalent	Well-Life Consultant
K010209	ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL	Jun 12, 2001	Substantially Equivalent	Biomedical Life Systems, Inc.
K001897	MULTI-STIM, MODEL MS-100	Jun 12, 2001	Substantially Equivalent	Metron Medical Australia, Pty, Ltd.
K010782	TRANSAMERICAN TENS	Apr 27, 2001	Substantially Equivalent	Transamerica Medical Systems
K002297	YORAMED, MODEL T-202	Mar 15, 2001	Substantially Equivalent	United Yoram Distributors, Inc.
K003369	LIFECARE COMPACT TENS DEVICE	Mar 08, 2001	Substantially Equivalent	Lifecare , Ltd.
K003507	MEDRELIEF	Feb 21, 2001	Substantially Equivalent	Healthonics, Inc.
K003591	TENSCARE, MODEL TENS XL-2	Feb 14, 2001	Substantially Equivalent	Tenscare, Ltd.
K993229	ANALGESIC PULSER, MODEL AP-439	Feb 02, 2001	Substantially Equivalent	Johari Electro-Tech Co.
K003487	STIMATE N601 TENS	Jan 24, 2001	Substantially Equivalent	Everyway Medical Instruments Co.,Ltd
K003258	MS-ONE, MODEL MS-1	Jan 12, 2001	Substantially Equivalent	Home Wellness West
K003231	HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3	Jan 12, 2001	Substantially Equivalent	Home Medical Services
K994266	FDTENS 2010	Jul 06, 2000	Substantially Equivalent	Fuji Dynamics Limited
K994265	MEDISANA DIGITAL TENS	Jul 06, 2000	Substantially Equivalent	Fuji Dynamics Limited
K984376	ENDOR 2000	Jun 07, 2000	Substantially Equivalent	T.C. Medical, Inc.
K994387	RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL	Mar 16, 2000	Substantially Equivalent	Woodside Biomedical, Inc.
K991397	TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS	Feb 11, 2000	Substantially Equivalent	Sein Electronics Co., Ltd.
K983907	RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R	Dec 09, 1999	Substantially Equivalent	Woodside Biomedical, Inc.
K993823	MED-4000	Nov 19, 1999	Substantially Equivalent	Micro Current Technology, Inc.
K992709	1818 TENS UNIT	Nov 09, 1999	Substantially Equivalent	138 Medical Supplies, Inc.
K990230	ELECTRO-NERVE STIMULATOR TENS, MODEL LX	Aug 19, 1999	Substantially Equivalent	Biomedical Life Systems, Inc.
K982961	MEDIPOINT	Jun 07, 1999	Substantially Equivalent	Medipoint , Ltd.
K982173	BUZBEE	Mar 11, 1999	Substantially Equivalent	Mwr Electronics Industrial Co.
K982967	RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R	Feb 23, 1999	Substantially Equivalent	Woodside Biomedical, Inc.
K984025	CARE TENS	Feb 10, 1999	Substantially Equivalent	Care Rehab, Inc.
K982324	VECTRA PRO MODELS 2 AND 4	Feb 01, 1999	Substantially Equivalent	Chattanooga Group, Inc.
K982321	VECTRA STIM MODELS 200 AND 400	Feb 01, 1999	Substantially Equivalent	Chattanooga Group, Inc.
K981976	ACUTRON MENTOR MODEL 961	Nov 25, 1998	Substantially Equivalent	Microcurrent Research, Inc.
K982410	SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICE	Nov 06, 1998	Substantially Equivalent	Rehabilicare, Inc.
K982436	RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-R	Oct 08, 1998	Substantially Equivalent	Woodside Biomedical, Inc.
K982221	PREMIER AP	Sep 22, 1998	Substantially Equivalent	American Imex
K964437	GB-1002 TENS WITH MASSAGE	Aug 14, 1998	Substantially Equivalent	Skylark Device Co., Ltd.
K973980	ACU-STIM TENS, AP-101082T	Jul 29, 1998	Substantially Equivalent	Apex Medical Corp.
K973979	MULTI-STIM TENS, AP-101081T	Jul 29, 1998	Substantially Equivalent	Apex Medical Corp.
K973978	MICRO II MICROCURRENT TENS	Jul 29, 1998	Substantially Equivalent	Apex Medical Corp.
K972244	NT2000	Feb 27, 1998	Substantially Equivalent	Bio-Medical Research, Ltd.
K980333	RELIEFBAND	Feb 18, 1998	Substantially Equivalent	Woodside Biomedical, Inc.
K974497	INTELECT	Jan 23, 1998	Substantially Equivalent	Chattanooga Group, Inc.
K965244	Z TECH TRANSCUTANEOUS NEURAL STIMULATION	Aug 27, 1997	Substantially Equivalent	Z Technologies, LLC
K962951	MODEL HS-2 TENS DEVICE	Aug 06, 1997	Substantially Equivalent	Technalithics Laboratories, Inc.
K965187	SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD	Aug 01, 1997	Substantially Equivalent	Sparta Surgical Corp.
K961050	RELIEFBAND TENS UNIT (MODIFICATION)	Aug 01, 1997	Substantially Equivalent	Maven Labs, Inc.
K940954	SYNAPTIC 3000	Jun 20, 1997	Substantially Equivalent	The Synaptic Corp.
K970429	BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T	Apr 29, 1997	Substantially Equivalent	Apex Medical Corp.
K953982	SIMPLEX TENS	Apr 25, 1997	Substantially Equivalent	Armstrong Industries, Inc.
K970203	EPIX VT	Apr 14, 1997	Substantially Equivalent	Empi
K963507	EXTRA TENS (RI-2500) NEO TENS (RI-2000E)	Mar 19, 1997	Substantially Equivalent	Comtek Intl., Corp.
K970696	S.P. 100	Mar 18, 1997	Substantially Equivalent	Lsi Intl., Inc.
K961809	SHE-LI TENS STIMULATOR MODEL SL-101 RX	Feb 26, 1997	Substantially Equivalent	Medi Consultants, Inc.
K963729	SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)	Feb 13, 1997	Substantially Equivalent	Skylark Device Co., Ltd.
K963125	M AND R REUSABLE ELECTRODES (MULTIPLE)	Feb 06, 1997	Substantially Equivalent	M & R Mfg., Inc.
K955470	ACTION POTENTIAL SIMULATION THERAPY DEVICE	Oct 22, 1996	Substantially Equivalent	Neurotech, Inc.
K961376	SMART-TENS, MODEL 456	Sep 12, 1996	Substantially Equivalent	Bio-Medical Research, Ltd.
K962910	SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY	Sep 05, 1996	Substantially Equivalent	Uni-Patch, Inc.
K962332	TENS/FES/NMES ELECTRODES	Jul 31, 1996	Substantially Equivalent	Uni-Patch, Inc.
K961749	TRANSAMERICA ELECTRODE	Jun 21, 1996	Substantially Equivalent	Transamerica Medical Systems
K954951	TAYLOR GENERAL PURPOSE MONITORING ELECTRODE	May 30, 1996	Substantially Equivalent	Taylor Industries, Inc.
K951951	FOCUS MODEL 795 UNIT	May 17, 1996	Substantially Equivalent	Empi
K960969	GALVA 5-T	May 15, 1996	Substantially Equivalent	Zimmer Elektromedizin GmbH
K951903	EPIX XL TENS UNIT	Mar 20, 1996	Substantially Equivalent	Empi
K954334	ACUPLUS	Jan 22, 1996	Substantially Equivalent	S.H.P. Intl. Pty., Ltd.
K946230	ENDURA REUSABLE TENS AND NMES ELECTRODES	Dec 22, 1995	Substantially Equivalent	Selectivemed Components, Inc.
K942631	ELECTROCARE	Oct 27, 1995	Substantially Equivalent	Waco Corp.
K940600	STIMULATOR, NERVE, TRANSCUTANEOUS, (PAIN RELIEF) 84-GZJ	Sep 29, 1995	Substantially Equivalent	Progressive Concepts, Inc.
K946299	PGS123 AND HVS-123	Jun 26, 1995	Substantially Equivalent	Skylark Device Co., Ltd.
K941923	STERILE TREATMENT ELECTRODE	Jun 02, 1995	Substantially Equivalent	Staodyne, Inc.
K933197	THE SIGNATURE SERIES, M IV	Jun 02, 1995	Substantially Equivalent	Progressive Electrical Therapeutics
K944280	TRANSAMERICAN CLASSIC TENS	May 15, 1995	Substantially Equivalent	Transamerica Biomedical, Inc.
K945676	GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES	Jan 30, 1995	Substantially Equivalent	Selectivemed Components, Inc.
K933237	MEDI-STIM, MODIFICATION	Sep 08, 1994	Substantially Equivalent	Mid-Canada Medical
K934051	BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)	Jul 11, 1994	Substantially Equivalent	Skylark Device Co., Ltd.
K932897	TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR	Jul 01, 1994	Substantially Equivalent	Nemectron GmbH
K931079	STAT-TENS	Jun 09, 1994	Substantially Equivalent	Skylark Device Co., Ltd.
K933368	TENS-IT	Jun 07, 1994	Substantially Equivalent	Electro Med Supply, Inc.
K935324	THERAPEUTIC ULTRASOUND AND STIMULATOR	May 26, 1994	Substantially Equivalent	Chattanooga Group, Inc.
K935395	NEURON II AND MICROTENS	Apr 15, 1994	Substantially Equivalent	Datran Corp.
K930102	PULSATOR 5000	Mar 23, 1994	Substantially Equivalent	Toys House Industrial Corp.
K932592	BRACE NEUTRALIZER	Mar 18, 1994	Substantially Equivalent	Smith and Nephew Donjoy, Inc.
K935132	HOME MICROCURRENT HMC	Mar 14, 1994	Substantially Equivalent	Medical Devices, Inc.
K934619	FLEXMATE	Feb 23, 1994	Substantially Equivalent	Medical Devices, Inc.
K932854	EZ GRIP DISPOSABLE ELECTRODES	Feb 22, 1994	Substantially Equivalent	Advanced Adhesives
K931108	EZ GRIP REUSABLE TENS/NMES ELECTRODES	Feb 01, 1994	Substantially Equivalent	Advanced Adhesives
K932611	NEUROMUSCULAR STIMULATOR	Jan 31, 1994	Substantially Equivalent	Myo/Kinetic Systems, Inc.
K932849	PMI TENS ELECTRODE	Jan 27, 1994	Substantially Equivalent	Pepin Mfg., Inc.
K931715	PURECARE AT-903 T.E.N.S.	Jan 27, 1994	Substantially Equivalent	Fuching Enterprise Co., Ltd.
K932320	NEUTRALIZER	Oct 06, 1993	Substantially Equivalent	Smith and Nephew Donjoy, Inc.
K931570	COM-TENS (SINGLE MODE)	Jun 18, 1993	Substantially Equivalent	Ems Dist.
K931424	MAXIMA I	Jun 04, 1993	Substantially Equivalent	Staodyne, Inc.
K926326	MICROCARE(TM)	Jun 01, 1993	Substantially Equivalent	American Imex
K923970	INTEGRITY 2	May 18, 1993	Substantially Equivalent	Medrotech Corp.
K922202	K-STIM CLEAR	May 17, 1993	Substantially Equivalent	Katecho, Inc.
K930865	STAODYN MAXIMA III	May 13, 1993	Substantially Equivalent	Staodyne, Inc.
K925821	COMFORTRON	May 07, 1993	Substantially Equivalent	M. D. Supply, Inc.
K915663	TENS PRO 900	Apr 15, 1993	Substantially Equivalent	Acuhealth (Usa) Pty. , Ltd.
K925686	THERA PULSE A ELECTRO NERVE STIMULATOR	Mar 18, 1993	Substantially Equivalent	Biomedical Life Systems, Inc.
K925898	MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS	Jan 28, 1993	Substantially Equivalent	Staodyne, Inc.
K925729	SD-602 SD MODE 11, SD-603 SD MOD 111	Jan 22, 1993	Substantially Equivalent	Skylark Device Co., Ltd.
K920266	TENS MODEL 240Z	Dec 03, 1992	Substantially Equivalent	Oms Medical Supplies, Inc.
K924545	MICRO MODE-TRANS ELECTRICAL NEURAL STIMULATOR	Dec 01, 1992	Substantially Equivalent	Mod Mode Medical
K923934	TX-3 SD	Oct 23, 1992	Substantially Equivalent	Skylark Device Co., Ltd.
K923935	SD-605 SD II PROGRAM	Oct 15, 1992	Substantially Equivalent	Skylark Device Co., Ltd.
K923298	MICRO 100,200,300, & 400 TENS	Oct 13, 1992	Substantially Equivalent	Skylark Device Co., Ltd.
K922690	PAIN-EEZ	Oct 13, 1992	Substantially Equivalent	International Center For Nutritional Research
K920260	INTELECT 600MP	Oct 13, 1992	Substantially Equivalent	Chattanooga Group, Inc.
K921679	K-DISPERSE	Oct 06, 1992	Substantially Equivalent	Katecho, Inc.
K923255	Q-SD	Oct 05, 1992	Substantially Equivalent	Quantitative Medicine, Inc.
K921828	TEAM-MC II	Sep 22, 1992	Substantially Equivalent	Henley Intl.
K921813	MED-TENS	Sep 11, 1992	Substantially Equivalent	Ems Dist.
K921110	TENS	Aug 14, 1992	Substantially Equivalent	Staodyne, Inc.
K915210	ELECTRO-NERVE STIMULATOR TENS MODEL MICRO PLUS-A	May 04, 1992	Substantially Equivalent	Biomedical Life Systems, Inc.
K912381	LOW BACK STRIP (OR) K-BACK	Jan 30, 1992	Substantially Equivalent	Katecho, Inc.
K910727	EXCEL MODEL 2110	Jan 17, 1992	Substantially Equivalent	Excel Medical Systems, Inc.
K914813	THERASTIM	Dec 31, 1991	Substantially Equivalent	Precision Electronics , Ltd.
K914871	TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL	Dec 18, 1991	Substantially Equivalent	Labeltape Meditect, Inc.
K914441	MENS 2000-D	Dec 17, 1991	Substantially Equivalent	Monad Corp.
K911963	MEDTRONIC MODEL 90002065 MF TENS SYSTEM	Dec 10, 1991	Substantially Equivalent	Medtronic Vascular
K913532	TX 3 TENS MODIFIED	Nov 22, 1991	Substantially Equivalent	Globalcare/Bay Medical Corp.
K912289	ULTIMA XS, MODIFICATION	Nov 22, 1991	Substantially Equivalent	American Imex
K901704	RELIEF BAND (T.E.N.S. DEVICE)	Nov 19, 1991	Substantially Equivalent	Maven Labs, Inc.
K912463	MICRO-Q	Nov 13, 1991	Substantially Equivalent	Quantitative Medicine, Inc.
K912460	Q-TENS	Nov 13, 1991	Substantially Equivalent	Quantitative Medicine, Inc.
K912178	BIO TENS 601, 606 AND 608 (3000)	Oct 25, 1991	Substantially Equivalent	Skylark Device Co., Ltd.
K911814	AXION 5, MODIFICATION	Oct 15, 1991	Substantially Equivalent	Ventura Medical Electronics
K905672	TEAM-MC	Oct 15, 1991	Substantially Equivalent	Henley Intl.
K913800	MEDA CROWN SERIES	Oct 04, 1991	Substantially Equivalent	Medical Electronic Assn.
K913522	SOLITENS MODIFIED	Aug 28, 1991	Substantially Equivalent	Innovative Designer Products, Inc.
K913594	DYNEX IIIB, MODEL 89002026	Aug 23, 1991	Substantially Equivalent	Medtronic Vascular
K910244	GLOBAL CARE MICRO II	Jul 09, 1991	Substantially Equivalent	Globalcare Intl., Inc.
K912348	SX90 (TM),MODEL 4800S	Jun 24, 1991	Substantially Equivalent	Medical Devices, Inc.
K905526	AGARRELIEF 10 TRANSCUTANEOUS ELEC NERVE STIMULATOR	Jun 21, 1991	Substantially Equivalent	Agar Ginosar Electronics
K910580	MICROSTIM 100 MODEL 2C	Jun 20, 1991	Substantially Equivalent	Microstim, Inc.
K902226	MY-O-MATIC 5000I	Jun 06, 1991	Substantially Equivalent	Monad Corp.
K905570	ELECTRO-NERVE STIMULATOR TENS MODEL BIOMED 2000/A	Jun 04, 1991	Substantially Equivalent	Biomedical Life Systems, Inc.
K905377	ELECTRO-NERVE STIMULATOR TENS MODEL SYSTEMS 2000/A	Jun 04, 1991	Substantially Equivalent	Biomedical Life Systems, Inc.
K905230	ELECTRO-NEVE STIMULATOR TENS MODEL BIOMED PLUS/A	Jun 04, 1991	Substantially Equivalent	Biomedical Life Systems, Inc.
K904388	POINTER F-3 TENS	Jun 04, 1991	Substantially Equivalent	Oms Medical Supplies, Inc.
K902102	COM-TENS: A NEUROSTIMULATOR	May 30, 1991	Substantially Equivalent	Apex Medical, Inc.
K904430	MENS FREEDOM MICRO	May 13, 1991	Substantially Equivalent	Monad Corp.
K904288	MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS	May 13, 1991	Substantially Equivalent	Monad Corp.
K904260	MENS-O-MATIC 3000	May 13, 1991	Substantially Equivalent	Monad Corp.
K904258	MICRO DERM	May 13, 1991	Substantially Equivalent	Monad Corp.
K904235	MENS-O-MATIC 2000	May 13, 1991	Substantially Equivalent	Monad Corp.
K904234	MENS-O-MATIC I	May 13, 1991	Substantially Equivalent	Monad Corp.
K904264	MODEL SW-103 SOLITANS STIMULATOR	May 09, 1991	Substantially Equivalent	Medical Consultants Intl. , Ltd.
K903394	GLOBALCARE MICRO 11 AND MICROCARE (TENS)	May 06, 1991	Substantially Equivalent	Globalcare Intl., Inc.
K904457	DIAL-AWAY PAIN	Apr 03, 1991	Substantially Equivalent	R.F.P., Inc.
K903161	MC II (TM), MODEL 7200S	Mar 27, 1991	Substantially Equivalent	Medical Devices, Inc.
K903577	DYNATRON 200 MICROCURRENT	Mar 15, 1991	Substantially Equivalent	Dynatronics Corp.
K903828	SYNAPS (TM)	Jan 18, 1991	Substantially Equivalent	Henley Intl.
K903128	STIMTRAC PC, CATALOG NO. 78-8510	Jan 02, 1991	Substantially Equivalent	Stimtech Products
K902822	MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE	Dec 19, 1990	Substantially Equivalent	Medical Design & Manufacturing Corp.
K896825	TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR	Nov 16, 1990	Substantially Equivalent	Infrasonics Corp.
K903017	MEGA-TENS DUAL CHANNEL T.E.N.S.	Oct 26, 1990	Substantially Equivalent	Futuremed Div. of Future Impex Corp.
K896408	QUANTUM	Sep 20, 1990	Substantially Equivalent	Stressmaster Systems, Inc.
K901417	ELECTROSTIM MST	Aug 28, 1990	Substantially Equivalent	Promatek Industries, Ltd.
K901726	LUMISCOPE MICRO 100	Aug 14, 1990	Substantially Equivalent	Lumiscope Co., Inc.
K896787	TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION	Jul 30, 1990	Substantially Equivalent	Saratoga Intl., Inc.
K900668	ACUDATA INDICATENS MODEL 5XS	Jun 22, 1990	Substantially Equivalent	Acudata Software
K900596	ACUDATA INDICATENS MODEL 5A	Jun 22, 1990	Substantially Equivalent	Acudata Software
K896620	NEUROTENS	Apr 26, 1990	Substantially Equivalent	Henley Intl.
K896226	LISS BODY STIMULATOR MODEL SBL501-M	Apr 10, 1990	Substantially Equivalent	Medical Consultants Intl. , Ltd.
K896948	ALPHA-STIM CS	Feb 23, 1990	Substantially Equivalent	Electromedical Products, Inc.
K883911	ELECTRO-ACUSCOPE 85	Feb 02, 1990	Substantially Equivalent	Biomedical Design Instruments
K895289	MEC-I-TRON MINI, MODEL M-2	Jan 19, 1990	Substantially Equivalent	Meyer Equipment Company, Inc.
K895183	REBOX II (TENS)	Jan 19, 1990	Substantially Equivalent	Rebox (Uk) , Ltd.
K895977	ACUSOURCE 600 (TENS)	Jan 09, 1990	Substantially Equivalent	Microcurrent Research, Inc.
K894964	K-2 TENS OR MED TENS	Jan 04, 1990	Substantially Equivalent	Oms Medical Supplies, Inc.
K895473	DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S	Dec 08, 1989	Substantially Equivalent	Medical Devices, Inc.
K895295	ULTIMA XS MICROCURRENT TENS	Nov 06, 1989	Substantially Equivalent	American Imex
K895334	TTS2600	Oct 30, 1989	Substantially Equivalent	Henley Intl.
K895211	TTS2700 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR	Oct 30, 1989	Substantially Equivalent	Henley Intl.
K895166	TTS2500	Oct 30, 1989	Substantially Equivalent	Henley Intl.
K895161	TTS2800	Oct 30, 1989	Substantially Equivalent	Henley Intl.
K883811	ELECTRONIC PAIN RELIEVERS	Oct 24, 1989	Substantially Equivalent	Jetco of America
K891992	TENZCARE STIMULATOR 6890	Oct 12, 1989	Substantially Equivalent	3M Company
K890087	ACUDATA INDICATENS MODEL 5M	Sep 07, 1989	Substantially Equivalent	Acudata Software
K894127	LUMISCOPE MODEL 1000/APCC MODEL 1000	Sep 06, 1989	Substantially Equivalent	Lumiscope Co., Inc.
K891118	STERLING TENS	Sep 06, 1989	Substantially Equivalent	Armstrong Industries, Inc.
K894388	ZIMMER TENS	Aug 10, 1989	Substantially Equivalent	American Imex
K884972	TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR	Jul 27, 1989	Substantially Equivalent	Futuremed Div. of Future Impex Corp.
K892408	NSD 8CS8 - TENS DEVICE	Jun 23, 1989	Substantially Equivalent	Future Medical Products, Inc.
K884869	MODIFIED MRL NEUROPROBE SYSTEM V	Jun 06, 1989	Substantially Equivalent	Medical Research Laboratories, Inc.
K890604	EMPI, MODEL 489, TENS	Jun 01, 1989	Substantially Equivalent	Empi
K890088	ACUDATA INDICATENS MODEL 5X	May 26, 1989	Substantially Equivalent	Acudata Software
K885190	MICRO-STIM 200	Apr 26, 1989	Substantially Equivalent	Theri-Teck, Inc.
K882980	REBUILDER BUCKET SYSTEM	Apr 24, 1989	Substantially Equivalent	Micromed, Inc.
K890705	MEDIMOD(TM), MODEL 8900	Mar 09, 1989	Substantially Equivalent	Medical Devices, Inc.
K884833	ULTRA 2000 (T.E.N.S.)	Feb 13, 1989	Substantially Equivalent	Maxima Intl., Inc.
K880744	ANESTY 10	Feb 09, 1989	Substantially Equivalent	Nihon Medix Co., Ltd.
K883188	T.E.N.S. UNIT SIGMA & TX-3	Dec 16, 1988	Substantially Equivalent	Diamond Medical Equipment, Inc.
K884210	TX-7 (TENS) (IC-1107)	Dec 12, 1988	Substantially Equivalent	Oms Medical Supplies, Inc.
K883236	CEFAR DUAL	Nov 16, 1988	Substantially Equivalent	Cefar Medical Products, Inc.
K884032	MORGAN TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR	Oct 13, 1988	Substantially Equivalent	Morgan Associates, Inc.
K882154	HEPAX (TENS)	Sep 30, 1988	Substantially Equivalent	Avl Scientific Corp.
K874818	TENSTAR	Sep 28, 1988	Substantially Equivalent	Healthcheck Corp.
K882631	EMPI MODEL 727,NMS	Sep 22, 1988	Substantially Equivalent	Empi
K875072	MODIFIED AMANA ELECTROTHERAPEUTIC SYSTEM	Sep 22, 1988	Substantially Equivalent	Amana Medical Group
K880426	ELECTROSTIMULATOR MODEL 808	Sep 19, 1988	Substantially Equivalent	Cornell Enterprises Co., Inc.
K881753	ALPHA-STIM 350	Aug 30, 1988	Substantially Equivalent	Electromedical Products, Inc.
K882820	MEDIPAC II EC (TM), MODEL 7900	Aug 29, 1988	Substantially Equivalent	Medical Devices, Inc.
K882943	MEDA ONE-STEP	Aug 19, 1988	Substantially Equivalent	Medical Electronic Assn.
K881708	INDICATENS 4X4	Aug 11, 1988	Substantially Equivalent	Acudata Software
K880042	ACUTRON	Aug 01, 1988	Substantially Equivalent	Davis Assoc.
K881832	DS-200 AND DS-400 T.E.N.S.	Jul 01, 1988	Substantially Equivalent	Delta Marketing, Inc.
K881704	EASY TENS	May 04, 1988	Substantially Equivalent	American Imex
K880492	INTERCEPT T.E.N.S. DEVICE	Apr 18, 1988	Substantially Equivalent	Medical Design & Manufacturing Corp.
K881114	EMPI MODEL 989, TENS	Apr 15, 1988	Substantially Equivalent	Empi
K881424	PREMIER 10S (TENS)	Apr 11, 1988	Substantially Equivalent	American Imex
K880980	SCHULDT* PC* - DUAL CHANNEL TENS	Apr 11, 1988	Substantially Equivalent	Schuldt Laboratories, Inc.
K880751	ULTIMA XS (TENS)	Apr 06, 1988	Substantially Equivalent	American Imex
K880452	LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE	Mar 24, 1988	Substantially Equivalent	Lumiscope Co., Inc.
K872704	AMASTIM 2000	Jan 22, 1988	Substantially Equivalent	Amatech International, Inc.
K873190	MEC-I-TRON, MODEL P-1	Dec 18, 1987	Substantially Equivalent	Meyer Equipment Company, Inc.
K874085	REBUILDER(TM)	Dec 11, 1987	Substantially Equivalent	Micromed, Inc.
K874550	TX-4(TENS) (SIGMA TENS)	Nov 20, 1987	Substantially Equivalent	Oms Medico, Inc.
K874333	TX-2(TENS)	Nov 20, 1987	Substantially Equivalent	Oms Medico, Inc.
K873357	ELECTROBLOC TRANS. ELECTRICAL NERVE BLOCK GENERA.	Oct 26, 1987	Substantially Equivalent	Th Charters, Inc.
K873420	GLOBALCARE(TENS)	Oct 08, 1987	Substantially Equivalent	Oms Medico, Inc.
K873484	120Z(TENS)	Sep 16, 1987	Substantially Equivalent	Oms Medico, Inc.
K872657	ULTRAPAC II SX PLUS (TM)	Aug 04, 1987	Substantially Equivalent	Medical Devices, Inc.
K872398	T.E.N.S. DEVICE MODEL SPL 2000	Jul 29, 1987	Substantially Equivalent	Spartan Laboratories, Inc.
K872399	T.E.N.S. DEVICE MODEL SPL 2000S	Jul 27, 1987	Substantially Equivalent	Spartan Laboratories, Inc.
K871722	MEDTENS(TM), MODEL NUMBER 7725	Jul 21, 1987	Substantially Equivalent	Medtronic Vascular
K871699	TX-3(TENS)	Jun 25, 1987	Substantially Equivalent	Oms Medico, Inc.
K871666	MODEL HP (OR MODEL 1001) TRANSCUTANEOUS STIMULATOR	Jun 25, 1987	Substantially Equivalent	Oriental Medical Supplies, Inc.
K871396	ACCULATOR 287EP	Jun 11, 1987	Substantially Equivalent	Accu Science Corp.
K871126	ELECTRO-NERVE STIMULATOR TENS MODEL C & B11, B11C	Jun 02, 1987	Substantially Equivalent	Biomedical Life Systems, Inc.
K871125	ELECTRO-NERVE STIMULATOR TENS MODEL B5/SKN	Jun 02, 1987	Substantially Equivalent	Biomedical Life Systems, Inc.
K870667	OMEGA T200	Apr 22, 1987	Substantially Equivalent	Henley Intl.
K870666	OMEGA T100	Apr 22, 1987	Substantially Equivalent	Henley Intl.
K864370	DYNATRON 1120 EPS (ELECTRICAL POINT STIMULATOR)	Apr 10, 1987	Substantially Equivalent for Some Indications	Dynatronics Laser Corp.
K870168	EMPI LOGIX MODEL 712 NMS, TENS	Apr 01, 1987	Substantially Equivalent	Empi
K864114	TENS DEVICE FOR RELIEF OF CHRONIC PAIN	Apr 01, 1987	Substantially Equivalent	Futuremed Div. of Future Impex Corp.
K862454	AGAR 7K TENS INSTRUMENT	Mar 25, 1987	Substantially Equivalent	Solcoor, Inc.
K870583	NEU-PULS(TENS) MODEL #295	Mar 17, 1987	Substantially Equivalent	Oms Medico, Inc.
K865063	UNI-PULS(TENS) MODEL #292	Mar 17, 1987	Substantially Equivalent	Oms Medico, Inc.
K864968	BACPAC (TM), MODEL 6500	Mar 13, 1987	Substantially Equivalent	Medical Devices, Inc.
K864956	DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.	Mar 09, 1987	Substantially Equivalent	La Jolla Technology, Inc.
K865048	ECLIPSE+, MODEL NUMBER 7723	Feb 26, 1987	Substantially Equivalent	Medtronic Vascular
K864368	SCHULDT* PLUS 8 T.E.N.S. DEVICE	Feb 26, 1987	Substantially Equivalent	Schuldt Laboratories, Inc.
K864735	A-TENS - MODEL AI-87	Feb 20, 1987	Substantially Equivalent	American Imex
K863469	CODETRON TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.	Feb 20, 1987	Substantially Equivalent	Cordis Corp.
K862352	ACCULATOR 487E	Feb 04, 1987	Substantially Equivalent	Accu Science Corp.
K862602	AXION IV GOLDLINE SERIES	Dec 22, 1986	Substantially Equivalent	Ventura Medical Electronics
K862450	MEDA 2500 T.E.N.S.	Nov 25, 1986	Substantially Equivalent	Watlow/Winona, Inc.
K863568	'MYOSTIM EX'	Oct 24, 1986	Substantially Equivalent	Electro Therapeutic Devices, Inc.
K863567	'TENSAID'	Oct 24, 1986	Substantially Equivalent	Electro Therapeutic Devices, Inc.
K861896	UNI-TENS XL TENS	Sep 09, 1986	Substantially Equivalent	Solcoor, Inc.
K861895	UNI-TENS	Sep 09, 1986	Substantially Equivalent	Solcoor, Inc.
K861894	AGAR 9K TENS	Sep 09, 1986	Substantially Equivalent	Solcoor, Inc.
K862355	TRANS-PULSE MODEL #1103	Aug 19, 1986	Substantially Equivalent	The Sun Co.
K862337	ULTRAPAC II SD (TM)	Aug 18, 1986	Substantially Equivalent	Medical Devices, Inc.
K861119	WALLANT NEUROLOGIX DUAL PUR NERVE/NEUROMUSCU STIMU	Aug 14, 1986	Substantially Equivalent	Wallant Intl. Trade, Inc.
K860847	WALLANT NEUROLOGIX GENERAL PURPOSE TENS	Aug 07, 1986	Substantially Equivalent	Wallant Intl. Trade, Inc.
K852061	PULSAR NEUROSTIMULATOR	Jul 18, 1986	Substantially Equivalent	Andromeda Research, Inc.
K861830	EMPI MODEL GLS 450, TENS	Jul 15, 1986	Substantially Equivalent	Empi
K861451	EMPI MODEL 720 NMS, TENS	Jul 03, 1986	Substantially Equivalent	Empi
K861214	SKYLARK GB 1000	Jun 18, 1986	Substantially Equivalent	Peleg Intl. Co.
K853898	SKYLARK MODEL 1001 TENS DEVICE	Jun 18, 1986	Substantially Equivalent	Peleg Intl. Co.
K861709	A TENS (MODEL AI-86)	May 16, 1986	Substantially Equivalent	American Imex
K860772	HARIKY, MODEL GK-7	May 09, 1986	Substantially Equivalent	K-Mot, Inc.
K861501	EXER-STIM 2	May 08, 1986	Substantially Equivalent	Th Charters, Inc.
K854316	FASTENS(TM)	Feb 28, 1986	Substantially Equivalent	Medical Devices, Inc.
K854476	KALMATE MODEL 3A	Feb 27, 1986	Substantially Equivalent	Medical Technology Systems, Inc.
K853992	VALLEY FORGE SCIEN-TENS UNIT & ACCESS. LEAD WIRE &	Feb 21, 1986	Substantially Equivalent	Valley Forge Scientific Corp.
K854761	MINIPAC PERSONAL TOUCH (TM)	Feb 14, 1986	Substantially Equivalent	Medical Devices, Inc.
K853885	MODEL RF-TENS-4 TRANSCUTANEOUS ELEC. NERVE STIMULA	Jan 30, 1986	Substantially Equivalent	Uniking Intl. Corp.
K854317	MINIPAC (TM)	Jan 21, 1986	Substantially Equivalent	Medical Devices, Inc.
K850855	TENS GB1001 DEVICE	Jan 09, 1986	Substantially Equivalent	Medicon, Inc.
K853836	NEURO PULSE II	Dec 09, 1985	Substantially Equivalent	Nagata Engineering Co.
K853442	MODEL 804 (TENS)	Dec 09, 1985	Substantially Equivalent	Oriental Medical Supplies, Inc.
K853719	TRANSCUTANEOUS ELECT. NERVE STIMUL-MYOSTIM 410	Dec 04, 1985	Substantially Equivalent	Electro Therapeutic Devices, Inc.
K853718	TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804	Dec 04, 1985	Substantially Equivalent	Electro Therapeutic Devices, Inc.
K851735	SYS STIM 206 MODEL ME206	Nov 19, 1985	Substantially Equivalent	Mettler Electronics Corp.
K853416	MES-TENS(TENS)	Nov 07, 1985	Substantially Equivalent	Oriental Medical Supplies, Inc.
K852838	ADVANCED MEDICAL PRODUCTS MES TENS	Aug 28, 1985	Substantially Equivalent	Advanced Medical Products, Inc.
K852837	ADVANCED MEDICAL PRODUCTS DR PULSE (TENS)	Aug 28, 1985	Substantially Equivalent	Advanced Medical Products, Inc.
K852836	ADVANCED MEDICAL PRODUCTS MINI-M (TENS)	Aug 28, 1985	Substantially Equivalent	Advanced Medical Products, Inc.
K844618	BIO-TENS	Aug 21, 1985	Substantially Equivalent	Bio-Research Associates, Inc.
K851511	ACCURATECARE I & ACCURATECARE II	Jul 01, 1985	Substantially Equivalent	Sunnex, Inc.
K851063	TENSMED II	Jun 04, 1985	Substantially Equivalent	Intermedics, Inc.
K851191	ELECTRO-NERVE STIMULATOR DISCO B9 TENS	May 31, 1985	Substantially Equivalent	Biomedical Life Systems, Inc.
K850860	AXON II BRAND OF DUAL CHANNEL TENS	May 31, 1985	Substantially Equivalent	Cassandra Electronics Corp.
K851185	ELECTRO-NERVE STIMULATOR B4/B400	May 23, 1985	Substantially Equivalent	Biomedical Life Systems, Inc.
K844680	CYBERTENS	Apr 05, 1985	Substantially Equivalent	Pori Associates, Inc.
K850004	TRANSCUTANEOUS NERVE STIMULATOR FOR PAIN RELIEF	Apr 02, 1985	Substantially Equivalent	Todd Medical, Inc.
K844994	THE MEHESZ STIMULATING SYSTEM	Mar 06, 1985	Substantially Equivalent	Campden Medical , Ltd.
K841427	ACCU-O-MATIC	Mar 05, 1985	Unknown	Myomed, Inc.
K844279	INTERCEPTOR, 662-01	Jan 24, 1985	Substantially Equivalent	Intermedics, Inc.
K844076	ELECTRO-NERVE STIMULATOR B5/SK700B	Jan 23, 1985	Substantially Equivalent	Biomedical Life Systems, Inc.
K842888	DUAL CHANNEL TENS, PULSAR REMOTE CONTRL	Jan 14, 1985	Substantially Equivalent	Cryomedics, Inc.
K844213	STIMTECH SD PATIENT 6089 #78-8050	Jan 10, 1985	Substantially Equivalent	Codman & Shurtleff, Inc.
K844212	STIMTECH SD CLINICIAN 6090 #78-8055	Jan 10, 1985	Substantially Equivalent	Codman & Shurtleff, Inc.
K844638	ELECTROCAINE MODEL SR-IV	Jan 08, 1985	Substantially Equivalent	Electrocaine Medical System
K843637	HEALTH PULSE FA-222 TRANSCUTANEOUS ELEC. NERVE STI	Nov 29, 1984	Substantially Equivalent	Therapeutic Equipment Corp.
K840099	MODEL 800-A VERI/PPR	Nov 28, 1984	Substantially Equivalent	Verite
K843822	MEA110	Oct 22, 1984	Substantially Equivalent	Canadian Medical Products
K843793	A-T TENS BELT	Oct 12, 1984	Substantially Equivalent	A-T Surgical Mfg. Co., Inc.
K841184	ELECTRO-NERVE STIMULATOR HL	Oct 04, 1984	Substantially Equivalent	Biomedical Life Systems, Inc.
K843119	ETI TENS BELT	Aug 17, 1984	Substantially Equivalent	Electro Therapeutic Devices, Inc.
K842812	MENTOR 150 PLUS TRANSCUTANEOUS ELEC.	Aug 08, 1984	Substantially Equivalent	Mentor Corp.
K842414	ECHO PULSE BURST	Jul 27, 1984	Substantially Equivalent	Rabar, Inc.
K840098	MODEL 811 VERI/TENS & PO	Jul 17, 1984	Substantially Equivalent	Verite
K841400	NEURO PULSE	Jun 15, 1984	Substantially Equivalent	Parker Laboratories, Inc.
K840964	SD PLUS CLINICIAN CAT# 78-8015	Apr 23, 1984	Substantially Equivalent	Codman & Shurtleff, Inc.
K840963	SD PLUS PATIENT CAT.#78-8010	Apr 23, 1984	Substantially Equivalent	Codman & Shurtleff, Inc.
K840497	OBSTETRIC PULSAR TWO CHANNEL TENS	Apr 16, 1984	Substantially Equivalent	Spembly Medical , Ltd.
K841045	EMPI MODEL 984 BASIX, TENS	Apr 13, 1984	Substantially Equivalent	Empi
K841000	BET MODEL 1010	Apr 13, 1984	Substantially Equivalent	Bioelectro Technologies
K840599	MULTI-STIMT	Apr 13, 1984	Substantially Equivalent	Joanco Medical Electronics , Ltd.
K840821	TRNS MI 8202	Apr 05, 1984	Substantially Equivalent	Medical Scientific Instruments
K833251	MODEL MK II TENS	Mar 05, 1984	Substantially Equivalent	European Electronic Systems, Ltd.
K834334	MEDAID DUAL CHANNEL TENS	Feb 13, 1984	Substantially Equivalent	Par Medex , Ltd.
K840040	HEALTH-UP	Feb 10, 1984	Substantially Equivalent	Kung-Ho International, Inc.
K833086	NEUROTRON 100	Jan 24, 1984	Substantially Equivalent	Neutro-Tronics
K834215	MINI-1 TRANSCUTANEOUS ELEC-NERVE STIM	Jan 03, 1984	Substantially Equivalent	Th Charters, Inc.
K831938	TRANSCUTANEOUS ELECTRONIC NERVE STIMU	Dec 22, 1983	Substantially Equivalent	Joseph M. Piocentile
K833037	POINTER F-3	Nov 29, 1983	Substantially Equivalent	Petra Intl. Co.
K833354	AUTO-TENS MODEL VI DUAL CHANNEL BATT	Nov 28, 1983	Substantially Equivalent	Physio Tronics Corp.
K831990	NEUROFLAX, EPK	Nov 28, 1983	Substantially Equivalent	Franks Electronics
K832160	ELECTRO-PULSE	Nov 14, 1983	Substantially Equivalent	Electro-Pulse
K832442	ELECTRO-ACUSCOPE	Oct 31, 1983	Substantially Equivalent	Kenneth J. Purcell
K832851	AGAR 8000 TENS	Oct 28, 1983	Substantially Equivalent	Kimed Industries, Inc.
K831487	ELECTRONEURAL STIMULATOR 12	Oct 28, 1983	Substantially Equivalent	Meridia 12 Corp.
K832337	AUTO-TENS MODEL V	Aug 31, 1983	Substantially Equivalent	Cbc Corp.
K832238	NEUROMOD COMFORT WAVE #7721 DUAL-	Aug 31, 1983	Substantially Equivalent	Medtronic Vascular
K830992	XCEL MODEL XE-1	Aug 12, 1983	Substantially Equivalent	Electrocaine Medical System
K831950	PULSAR #B SINGLE CHANNEL TENS-PULSAR D	Aug 01, 1983	Substantially Equivalent	Spembly Medical , Ltd.
K831850	NEURO-PULSER 2 TRANSCUTAN. ELEC. NERVE	Jul 19, 1983	Substantially Equivalent	Th Charters, Inc.
K831147	OMNIPROBE ELECTRICAL NERVE STIMULATOR	Jul 18, 1983	Substantially Equivalent	Omni Intl., Inc.
K831145	ALPHA-STIM 350	Jul 07, 1983	Substantially Equivalent	Electromedical Products, Inc.
K831144	ALPHA-STIM 2000	Jun 30, 1983	Substantially Equivalent	Electromedical Products, Inc.
K831413	SPEC IISX	Jun 08, 1983	Substantially Equivalent	Medical Devices, Inc.
K830747	PC 2909A-HEALTH PULSE CONTROL STIMULATOR	May 30, 1983	Substantially Equivalent	J.A. Preston Corp.
K830932	NYNEX II	Apr 18, 1983	Substantially Equivalent	La Jolla Technology, Inc.
K830792	PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE	Mar 29, 1983	Substantially Equivalent	Bomed Medical Mfr., Ltd.
K823466	AUTO-TENS MODEL III DUAL CHANNEL REPLACE	Mar 07, 1983	Substantially Equivalent	Cbc Corp.
K823467	AUTO-TENS MODEL I DISPOS. SINGLE CHAN	Feb 07, 1983	Substantially Equivalent	Cbc Corp.
K823465	AUTO-TENS MODEL II SINGLE CHANNEL	Feb 02, 1983	Substantially Equivalent	Cbc Corp.
K823464	AUTO-TENS MODEL IV -DUAL CHANNEL FULL	Feb 02, 1983	Substantially Equivalent	Cbc Corp.
K823742	NEUROMOD COMPLEMENT #7724 DUAL CHANNEL	Jan 21, 1983	Substantially Equivalent	Medtronic Vascular
K823497	WRIGHT CARE	Jan 07, 1983	Substantially Equivalent	Dow Corning Wright
K823299	MODEL 402P SEQUENCER FOR EMPI TEMS DEV	Dec 15, 1982	Substantially Equivalent	Epmi, Inc.
K823002	DENDRITE VM-TRANSCUTANEOUS ELEC. NERVE	Nov 17, 1982	Substantially Equivalent	Tri W-G, Inc.
K822929	VERIL/PPR PERSONAL PAIN RELIEVER #800	Nov 17, 1982	Substantially Equivalent	Verite
K822841	THE EMD TENZ PAIN CONTROL SYSTEM	Nov 16, 1982	Substantially Equivalent	Electro Medical Development
K822854	PRO MED 100	Oct 15, 1982	Substantially Equivalent	Rebco Trading Co.
K822600	NEUROMEDICS ORIONS #660-01	Sep 24, 1982	Substantially Equivalent	Intermedics, Inc.
K821571	TP440 ORTHOPROBE	Jul 21, 1982	Substantially Equivalent	Grove Video Corp.
K821523	OMNI TENS	Jun 16, 1982	Substantially Equivalent	Omni Intl., Inc.
K821363	TRANS-Q	May 28, 1982	Substantially Equivalent	Chesapeake Medical Assoc.
K820651	MODEL 860-1 VERI/PROBE	Apr 29, 1982	Substantially Equivalent	Verite
K820326	BIGSTON TRANSCUTANEOUS NERVE STIMULAT	Apr 29, 1982	Substantially Equivalent	Canadian Medical Products
K820678	SYSTEM 10	Mar 23, 1982	Substantially Equivalent	Biostim, Inc.
K813601	E.W.L. P-TENS MODEL(TENS	Mar 19, 1982	Substantially Equivalent	Electronic Waveform Laboratory, Inc.
K820496	TENS MODEL 8201	Mar 15, 1982	Substantially Equivalent	Medical Scientific Instruments
K813569	EMOTENS	Feb 24, 1982	Substantially Equivalent	Electro Medica Office
K812612	TNS MK I STIMULATOR	Feb 18, 1982	Substantially Equivalent	Edu Kit , Ltd.
K813283	10D (TENS DEVICE)	Feb 10, 1982	Substantially Equivalent	Staodynamics, Inc.
K813501	TRANSCUTANEOUS ELEC. NERVE STIMULATOR	Dec 29, 1981	Substantially Equivalent	Empi
K813100	BIO-STIMULATOR, MODEL 400	Nov 27, 1981	Substantially Equivalent	Med-Western Electronics, Inc.
K812432	HEALTH-UP	Nov 06, 1981	Substantially Equivalent	Wfx Industries, Inc.
K812704	NEUROMED SELECTRA #7720	Oct 19, 1981	Substantially Equivalent	Medtronic Vascular
K812138	TENS DEVICE	Aug 20, 1981	Substantially Equivalent	Western Advanced Technology, Inc.
K811499	TENSMAX	Aug 20, 1981	Substantially Equivalent	Anritsu America Co.
K812036	NEUROGAR III	Aug 07, 1981	Substantially Equivalent	Inter Med Industries, Inc.
K811351	VERI-FIER	Jul 30, 1981	Substantially Equivalent	Verite
K811939	VITATRON 88	Jul 23, 1981	Substantially Equivalent	Vitatronics
K811345	INSIGHT	Jul 10, 1981	Substantially Equivalent	Staodynamics, Inc.
K811095	TRANSCUTANEOUS ELECTRICAL NERVE	Jul 01, 1981	Substantially Equivalent	Acutec Corporation, Inc.
K810841	MEDAID	Jun 12, 1981	Substantially Equivalent	C.V.I., Inc.
K811224	MINISTIM	Jun 02, 1981	Substantially Equivalent	Medical Design & Manufacturing Corp.
K811012	TENS-O-MATIC	Jun 01, 1981	Substantially Equivalent	O-Matic, Inc.
K810593	NEUROPAC ULTRA I	Mar 13, 1981	Substantially Equivalent	Medical Devices, Inc.
K803121	MENTOR 150 TRANSCUTANEOUS NERVE STIMULA	Dec 30, 1980	Substantially Equivalent	George H. Frisch
K803113	MENTOR 402 TRANSCUTANEOUS ELEC. STIMULAT	Dec 30, 1980	Substantially Equivalent	George H. Frisch
K802779	LOAD SENTINEL II, TRANS. ELEC. NERVE	Dec 10, 1980	Substantially Equivalent	Powers Medical Systmes
K802678	TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR	Dec 10, 1980	Substantially Equivalent	General Medical Industries, Inc.
K802507	TENSMATE EMPIMODEL 9980	Dec 01, 1980	Substantially Equivalent	Empi
K802063	SPEMBLY 9000 & 9300	Oct 03, 1980	Substantially Equivalent	Spembly Medical , Ltd.
K802227	ANASTIM II TRANSCUTANEOUS ELECTRICAL	Sep 26, 1980	Substantially Equivalent	Biostim, Inc.
K801459	ELECTRO-ACUSCOPE-70	Aug 20, 1980	Substantially Equivalent	Nebrensky Corp.
K801576	NEUROGAR III-TRANSCUT. ELEC. NERVE STIM	Aug 14, 1980	Substantially Equivalent	Inter Med Industries, Inc.
K800576	CYCLOPAC CP100 TENS BANDAGE	May 23, 1980	Substantially Equivalent	Cyclotechnical Medical Indust., Inc.
K801112	EMPI MODEL 910S, TENS	May 14, 1980	Substantially Equivalent	Empi
K800758	TENZCARE DUAL-CHANNEL STIMULATOR	Apr 10, 1980	Substantially Equivalent	3M Company
K800630	TYPE 4000 TRANSCUTANEOUS ELEC. STIM.	Apr 02, 1980	Substantially Equivalent	Frye Electronics, Inc.
K792473	THERAPETTE, MODEL NO MH-100	Dec 20, 1979	Substantially Equivalent	Technical Resources, Inc.
K792502	TENS 4100	Dec 18, 1979	Substantially Equivalent	Staodynamics, Inc.
K792522	MODEL 980D TENS NEUROPACER	Dec 13, 1979	Substantially Equivalent	Empi
K792474	TENS 4500	Dec 13, 1979	Substantially Equivalent	Staodynamics, Inc.
K792311	MEDTRONIC MODEL 7728 NEUROMOD	Nov 21, 1979	Substantially Equivalent	Medtronic Vascular
K791834	NURITE II VRM DUAL (ELEC. NERVE STIM.)	Oct 02, 1979	Substantially Equivalent	Bio-Medical Systems Corp.
K791833	NURITE II VRM SINGLE (ELEC. NERVE STIM)	Oct 02, 1979	Substantially Equivalent	Bio-Medical Systems Corp.
K791187	MODEL 810 VERI/TGS	Aug 22, 1979	Substantially Equivalent	Verite
K791158	STIMULATOR, ELECTRICAL NERVE	Jul 03, 1979	Substantially Equivalent	Electreat, Inc.
K782164	STIMULATOR, MODEL 1-600 ELECTRIC NERVR	Mar 08, 1979	Substantially Equivalent	Ipco Corp.
K790011	STIMULATOR, MENTOR 100 NERVE	Mar 02, 1979	Substantially Equivalent	Mentor Corp.
K790189	ELECTREAT MODEL 250 TRANSCUTANEOUS STIM	Feb 08, 1979	Substantially Equivalent	Electreat, Inc.
K782127	STIMULATOR, ELECTRICAL NERVE	Jan 05, 1979	Substantially Equivalent	Somatronics, Inc.
K782075	STIMULATOR, MODEL 7727	Dec 14, 1978	Substantially Equivalent	Medtronic Vascular
K781829	NEUROPAC ULTRA II	Nov 22, 1978	Substantially Equivalent	Medical Devices, Inc.
K781670	STIMULATOR, E.S.I. NEURO	Nov 07, 1978	Substantially Equivalent	Evolutionary Systems, Inc.
K781683	NURITE II, SINGLE	Oct 13, 1978	Substantially Equivalent	Bio-Medical Systems Corp.
K781565	ELECTRICAL NERVE STIMULATOR MODEL 6035	Oct 11, 1978	Substantially Equivalent	Stimulation Technology, Inc.
K781277	STIMULATOR, NERVE, TRANSCUTANEOUS	Sep 27, 1978	Substantially Equivalent	Psitron
K780828	NURITE II	May 31, 1978	Substantially Equivalent	Bio-Medical Systems Corp.
K780698	STIMULATORS, NERVE, ELECTRICAL	May 12, 1978	Substantially Equivalent	Med General
K780444	NERVTRON-RX	Apr 19, 1978	Substantially Equivalent	Medix Corp.
K780186	NEUROMOD STIMULATOR MODEL 3723	Mar 02, 1978	Substantially Equivalent	Medtronic Vascular
K772224	NERVE STIMULATOR, ELEC. TRANSCUTANEOUS	Dec 15, 1977	Substantially Equivalent	Stimulation Technology, Inc.
K771885	IMPORTED PAIN CONTROL DEVICE	Nov 02, 1977	Substantially Equivalent	Empi
K771122	VERI/CTGS MODEL 850	Aug 04, 1977	Substantially Equivalent	Verite Scientific, Inc.
K761053	ANODYNE II-ELECTRICAL NEURO STIMULATOR	Nov 30, 1976	Substantially Equivalent	Rich-Mar Corp.