Electrode, Cutaneous
The Cutaneous Electrode is a surface electrode placed on the skin for use in neurological monitoring procedures such as electroencephalography (EEG), nerve conduction studies, or evoked potential testing. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GXY under regulation 21 CFR 882.1320 in the Neurology specialty. It is eligible for third-party 510(k) review.
Basic Information
- Product Code
- GXY
- Device Class
- FDA class 2
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 427 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243788 | IceCap product line | Mar 13, 2025 | Substantially Equivalent | Bioserenity Medical Devices Group |
| K243243 | Delphi MCS Electrode Cap | Feb 06, 2025 | Substantially Equivalent | QuantalX Neuroscience, Ltd. |
| K241512 | Electrode Pad | Jan 15, 2025 | Substantially Equivalent | ShenZhen Deliduo Medical Technology Co.,Ltd |
| K242326 | Wave Electrode (AE02-60); Wave Electrode (AE02-50) | Jan 02, 2025 | Substantially Equivalent | BionIT Labs Srl |
| K241160 | CAIs Sensor (CAIs-001) | Dec 13, 2024 | Substantially Equivalent | BrainU Co.,Ltd. |
| K240575 | WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) | Nov 25, 2024 | Substantially Equivalent | eemagine Medical Imaging Solutions GmbH |
| K242346 | Grass® MR Conditional/CT Cup Electrodes | Aug 29, 2024 | Substantially Equivalent | Natus Manufacturing Limited |
| K240108 | Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01) | Jun 10, 2024 | Substantially Equivalent | Gymmax Technology Shenzhen Co., Ltd. |
| K240884 | Glide (91000-GL-X) | Apr 15, 2024 | Substantially Equivalent | Infinite Biomedical Technologies, LLC |
| K240668 | Amydi-med Disposable Non-invasive EEG electrodes | Mar 19, 2024 | Substantially Equivalent | Shenzhen Amydi-med Electrics Tech Co., Ltd. |
| K232995 | Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe | Jan 11, 2024 | Substantially Equivalent | Shenzhen Roundwhale Technology Co., Ltd. |
| K221199 | Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) | Dec 19, 2023 | Substantially Equivalent | Green Island International TCM Group Limited |
| K231167 | Conductive Silicone Rubber Electrode | Aug 09, 2023 | Substantially Equivalent | Guangzhou Xinbo Electronic Co., Ltd. |
| K231164 | Conductive carbon film electrode | Aug 09, 2023 | Substantially Equivalent | Guangzhou Xinbo Electronic Co., Ltd. |
| K232052 | Ceribell Instant EEG Headband | Aug 08, 2023 | Substantially Equivalent | Ceribell, Inc. |
| K221589 | Starly pad | Mar 24, 2023 | Substantially Equivalent | Shenzhen Xingyuanli Technology Co., Ltd. |
| K230533 | Motive Electrode | Mar 22, 2023 | Substantially Equivalent | CyMedica Orthopedics, Inc. |
| K223086 | Ceribell Instant EEG Headcap | Mar 22, 2023 | Substantially Equivalent | Ceribell, Inc. |
| K222671 | DeltaScan Patch | Feb 02, 2023 | Substantially Equivalent | Prolira B.V. |
| K222863 | Garment Electrodes | Feb 01, 2023 | Substantially Equivalent | Tone-A-Matic International Inc. |
| K222252 | Self-adhesive Electrode | Jan 19, 2023 | Substantially Equivalent | Shenzhen Roundwhale Technology Co., Ltd. |
| K220448 | Disposable Non-invasive EEG Sensor | Jan 19, 2023 | Substantially Equivalent | Shenzhen Med-link Electronics Tech Co., Ltd. |
| K223738 | Alpha Control Liner System (ACLS) | Jan 11, 2023 | Substantially Equivalent | Coapt |
| K223775 | EZ-STIK Electrodes | Jan 03, 2023 | Substantially Equivalent | South Dakota Partners |
| K223605 | ControlSeal Electrode (ELSB) | Dec 30, 2022 | Substantially Equivalent | Coapt |
| K222453 | Self-adhesive Electrode | Nov 04, 2022 | Substantially Equivalent | Guangdong Comytens Medical Technology Co., Ltd |
| K220002 | Dexus Prosthetics System (Model: MSL1, MSR1) | Sep 09, 2022 | Substantially Equivalent | Zhejiang Qiangnao Technology Co.,Ltd |
| K213884 | Disposable EEG cable | May 06, 2022 | Substantially Equivalent | Shenzhen Changke Connect Electronics Co., Ltd. |
| K213879 | Self-adhesive Electrode | Jan 05, 2022 | Substantially Equivalent | Bozhou Rongjian Medical Appliance Co.,Ltd. |
| K210383 | Wrap Accessory Electrodes | Nov 12, 2021 | Substantially Equivalent | Hi-Dow International Inc. |
| K211315 | Comby EEG Caps | Nov 09, 2021 | Substantially Equivalent | Pamel d.o.o |
| K212191 | Adhesive Electrodes | Oct 06, 2021 | Substantially Equivalent | Voncare Medical Device Co., Ltd |
| K210448 | Adhesive Electrode | Aug 31, 2021 | Substantially Equivalent | Shaoxing Yingtuo Healthcare Co.,Ltd. |
| K210805 | Ceribell Instant EEG Headband | Aug 30, 2021 | Substantially Equivalent | Ceribell, Inc. |
| K202636 | Metallic Fabric Electrodes | Aug 16, 2021 | Substantially Equivalent | Guangzhou Xinbo Electronic Co., Ltd. |
| K211839 | Electrode Market Disposable Surface Electrodes | Jul 28, 2021 | Substantially Equivalent | Electrode Market Co.,Ltd. |
| K203158 | BioWave BioWraps | Jul 08, 2021 | Substantially Equivalent | BioWave Corporation |
| K200942 | Well-Life Garment Electrodes (GM Series) | Jun 01, 2021 | Substantially Equivalent | Well-Life Healthcare Limited |
| K202913 | NeuroCap (Model DEC22) | Mar 05, 2021 | Substantially Equivalent | Memory MD Inc |
| K203079 | MR Conditional Sticky Pad Electrode | Feb 09, 2021 | Substantially Equivalent | Rhythmlink International, LLC |
| K192568 | Jiajian Self-Adhesive Electrode | Feb 03, 2021 | Substantially Equivalent | Wuxi Jiajian Medical Instrument Co., Ltd |
| K200540 | BRAINSTREAM Disposable Deep Cup EEG Electrodes | Jun 01, 2020 | Substantially Equivalent | CONMED Corporation |
| K190118 | Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) | May 13, 2020 | Substantially Equivalent | Guangzhou Xinbo Electronic Co., Ltd. |
| K200162 | Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) | Apr 21, 2020 | Substantially Equivalent | Wuhan Greentek Pty Ltd. |
| K192564 | Disposable Gold Cup EEG Electrodes | Jan 21, 2020 | Substantially Equivalent | Dymedix Diagnostics, Inc. |
| K191179 | Myo Plus | Sep 04, 2019 | Substantially Equivalent | Otto Bock Healthcare Products GmbH |
| K191225 | EEG Electrode Template | Aug 05, 2019 | Substantially Equivalent | Rhythmlink International, LLC |
| K190617 | Wrap accessory electrodes | Jul 02, 2019 | Substantially Equivalent | Hi-Dow International Inc. |
| K190700 | ELECTRODES PAD | Jun 14, 2019 | Substantially Equivalent | Shenzhen Bestpad Technology Development Co., Ltd |
| K191083 | COMPLETE CONTROL System Gen2 | May 24, 2019 | Substantially Equivalent | Coapt, LLC |
| K190416 | Dome Electrode | Apr 04, 2019 | Substantially Equivalent | Coapt, LLC |
| K180232 | DAEHAN Disposable CUP Electrodes | Apr 03, 2019 | Substantially Equivalent | Daehan Medical Systems Co., Ltd. |
| K183154 | SM Electrodes | Mar 26, 2019 | Substantially Equivalent | Hong Qiangxing (Shen Zhen) Electronics Limited |
| K182111 | DL Self-adhesive Electrode | Jan 17, 2019 | Substantially Equivalent | Shaoxing DL Healthcare Co., Ltd. |
| K182757 | Espire Elbow Pro, Espire Elbow Hybrid | Nov 29, 2018 | Substantially Equivalent | College Park Industries, Inc. |
| K180247 | DAEHAN Adhesive Surface Electrodes | Nov 01, 2018 | Substantially Equivalent | Daehan Medical Systems Co., Ltd. |
| K182112 | Sense System with IBT Electrodes | Oct 05, 2018 | Substantially Equivalent | Infinite Biomedical Technologies, LLC |
| K181234 | Self-adhesive Electrode | Aug 07, 2018 | Substantially Equivalent | Dong Guan Ou Kang Electronics CO., LTD |
| K180865 | ZMI Self-Adhesive Electrodes | Jun 28, 2018 | Substantially Equivalent | ZMI Electronics, Ltd. |
| K171798 | Silverwear Silver Pro Garment Device | Jun 01, 2018 | Substantially Equivalent | Media Plus, LLC |
| K180773 | Reusable and Self-Adhesive Electrodes | May 22, 2018 | Substantially Equivalent | Shaoxing DongZhi Electrical Technology Co., Ltd. |
| K180524 | EEG-Now | May 18, 2018 | Substantially Equivalent | EncephaloDynamics, Inc. |
| K172866 | NeuroCap | Apr 27, 2018 | Substantially Equivalent | Memory MD INC |
| K172887 | XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) | Apr 19, 2018 | Substantially Equivalent | Guangzhou Xinbo Electronic Co., Ltd. |
| K173571 | Element System with IBT Electrodes | Mar 21, 2018 | Substantially Equivalent | Infinite Biomedical Technologies, LLC |
| K173186 | S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D | Feb 28, 2018 | Substantially Equivalent | Everyway Medical Instruments Co., Ltd. |
| K171722 | Electrodes with snap / Electrodes with pigtail | Jan 10, 2018 | Substantially Equivalent | Shenzhen Konmed Technology Co., Ltd |
| K171721 | Electrodes with silver conductive | Jan 05, 2018 | Substantially Equivalent | Shenzhen Konmed Technology Co., Ltd |
| K171102 | Ives MR Conditional Cup Electrode | Dec 21, 2017 | Substantially Equivalent | Ives EGG Solutions |
| K171381 | Adhesive Electrodes | Dec 13, 2017 | Substantially Equivalent | ShenZhen Quality Medical Technology Co.,Ltd |
| K172503 | MR Conditional Cup Electrode, MR Conditional Webb Electrode | Dec 01, 2017 | Substantially Equivalent | Rhythmlink International, LLC |
| K172703 | Disposable Snap Electrode | Nov 13, 2017 | Substantially Equivalent | Embla Systems |
| K171459 | Ceribell Instant EEG Headband | Aug 21, 2017 | Substantially Equivalent | Ceribell, Inc. |
| K170744 | Adhesive Electrodes | May 08, 2017 | Substantially Equivalent | Reno Medical Ltd. |
| K162460 | WAVi Headset and WAVi eSoc Single Use Electrode Contacts | Apr 28, 2017 | Substantially Equivalent | WAVI, CO |
| K162891 | Complete Control System | Apr 14, 2017 | Substantially Equivalent | COAPT, LLC |
| K163547 | MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 | Apr 11, 2017 | Substantially Equivalent | NEUROVIRTUAL USA, INC. |
| K161282 | FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W | Oct 30, 2016 | Substantially Equivalent | MEDICO ELECTRODES INTERNATIONAL LTD. |
| K160081 | TENS Electrodes | Oct 19, 2016 | Substantially Equivalent | CATHAY MANUFACTURING CORP. |
| K160138 | Adhesive Electrodes | Aug 11, 2016 | Substantially Equivalent | GMDASZ MANUFACTURING CO., LTD |
| K153019 | Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes | Mar 21, 2016 | Substantially Equivalent | BIO PROTECH, INC. |
| K152815 | Mailuokang Self-adhesive Electrode | Mar 08, 2016 | Substantially Equivalent | SHENZHEN MAILUOKANG TECHNOLOGY CO., LTD. |
| K152648 | Ennova Self-adhesive Electrode | Feb 18, 2016 | Substantially Equivalent | Suzhou Ennova Electronics Technology Co.,Ltd |
| K151693 | Dr-Ho's Foot Pad Electrode | Oct 09, 2015 | Substantially Equivalent | DRTV ASIA LTD |
| K151576 | Neon EEG | Sep 29, 2015 | Substantially Equivalent | Incereb Ltd |
| K150971 | Zekang Self-adhesive Electrode | Aug 25, 2015 | Substantially Equivalent | Jiangsu Zekang Medical Technology Co., Ltd |
| K151033 | Philips Self-Adhesive Electrodes | Jul 28, 2015 | Substantially Equivalent | PHILIPS CONSUMER LIFESTYLE |
| K142159 | DISPOSABLE PRE-GELLED SURFACE ELECTRODE | Jun 03, 2015 | Substantially Equivalent | ROCHESTER ELECTRO MEDICAL, INC. |
| K143506 | BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES) | Apr 16, 2015 | Substantially Equivalent | COVIDIEN |
| K142099 | CUTANEOUS ELECTRODES | Nov 17, 2014 | Substantially Equivalent | BIO PROTECH, INC. |
| K140586 | ASCEND ELECTRODE | Nov 17, 2014 | Substantially Equivalent | NEUROMETRIX, INC. |
| K141342 | WEARABLE THERAPY GARMENTS | Nov 14, 2014 | Substantially Equivalent | AXIOBIONICS LLC |
| K141076 | GARMENT ELECTRODES | Nov 14, 2014 | Substantially Equivalent | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
| K131720 | HIVOX SELF ADHESIVE ELECTRODE GEL PADS | Jul 25, 2014 | Substantially Equivalent | HIVOX BIOTEK, INC. |
| K123795 | AXON-BUS PROSTHETIC SYSTEM | Jun 03, 2014 | Substantially Equivalent | OTTO BOCK AUSTRIA |
| K140340 | SKINTACT | May 21, 2014 | Substantially Equivalent | LEONHARD LANG GMBH |
| K132422 | PALS PLATINUM NEUROSTIMULATION ELECTRODES | Feb 13, 2014 | Substantially Equivalent | AXELGAARD MFG. CO., LTD. |
| K132057 | DYNATRON PELTIER THERMOSTIM PROBE | Jan 24, 2014 | Substantially Equivalent | DYNATRONICS CORP. |
| K132998 | WANDY SELF-ADHESIVE ELECTRODES | Dec 20, 2013 | Substantially Equivalent | WANDY RUBBER INDUSTRIAL CO., LTD |
| K132588 | ADHESIVE ELECTRODES | Nov 22, 2013 | Substantially Equivalent | TOP-RANK HEALTH CARE EQUIPMENT CO., LTD. |
| K130987 | VALUTRODE NEUROSTIMLATION ELECTRODES | Jul 17, 2013 | Substantially Equivalent | AXELGAARD MFG. CO., LTD. |
| K130816 | INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE) | Jun 21, 2013 | Substantially Equivalent | NEURO RESOURCE GROUP, INC. |
| K130287 | MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE | May 30, 2013 | Substantially Equivalent | RHYTHMLINK INTERNATIONAL, LLC |
| K123915 | DE48-PLUS | Apr 24, 2013 | Substantially Equivalent | GRASS TECHNOLOGIES, AN ASTRO-MED, INC. PRODUCT GRO |
| K113375 | ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE | Jan 25, 2013 | Substantially Equivalent | ESWALLOW USA |
| K122376 | PMT TRUSCAN SURFACE ELECTRODE | Dec 19, 2012 | Substantially Equivalent | PMT CORP. |
| K121816 | SENSUS ELECTRODE | Nov 26, 2012 | Substantially Equivalent | NEUROMETRIX, INC. |
| K121483 | REUSABLE CUTANEOUS ELECTRODE | Oct 15, 2012 | Substantially Equivalent | AMPCARE, LLC |
| K120835 | DYNATRON THERMOSTIM PROBE-DONE | Aug 20, 2012 | Substantially Equivalent | DYNATRONICS CORPORATION |
| K120494 | DISPOSABLE ADHESIVE SURFACE ELECTRODE | Jun 11, 2012 | Substantially Equivalent | SPES MEDICA S.R.L. |
| K120516 | LONG LIFE PADTM | May 17, 2012 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K112319 | ELECTRO-CAP SYSTEM | Jan 27, 2012 | Substantially Equivalent | ELECTRO-CAP INTL., INC. |
| K112312 | THERATRODE | Jan 25, 2012 | Substantially Equivalent | PHOENIX MEDICAL DEVICES, LLP |
| K112934 | NEUROTECH RECOVERY | Jan 20, 2012 | Substantially Equivalent | BIO-MEDICAL RESEARCH, LTD. |
| K111737 | DISPOSABLE ELECTRODE | Oct 14, 2011 | Substantially Equivalent | SANIBEL SUPPLY |
| K111270 | REUSABLE STIMULATING ELECTRODES | Sep 13, 2011 | Substantially Equivalent | BIO PROTECH, INC. |
| K110289 | FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE | Aug 30, 2011 | Substantially Equivalent | XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD. |
| K103719 | LIFECARE CONDUCTIVE GARMENTS | Aug 24, 2011 | Substantially Equivalent | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
| K110223 | WAVEGUARD (TM) EEG CAP | Jun 29, 2011 | Substantially Equivalent | EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH |
| K102614 | AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 | Jun 03, 2011 | Substantially Equivalent | BIO-MEDICAL RESEARCH, LTD. |
| K102842 | ADHESIVE ELECTRODES | Dec 02, 2010 | Substantially Equivalent | RENO MEDICAL LIMITED |
| K100418 | SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE | Sep 03, 2010 | Substantially Equivalent | COVIDIEN |
| K092828 | STATNET, MODEL 3100 | Jan 29, 2010 | Substantially Equivalent | HYDRODOT, INC |
| K091762 | DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE | Dec 22, 2009 | Substantially Equivalent | COVIDIEN |
| K092546 | GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM | Dec 18, 2009 | Substantially Equivalent | GMDASZ MANUFACTURING CO., LTD |
| K092793 | MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411 | Dec 07, 2009 | Substantially Equivalent | BIO-MEDICAL RESEARCH, LTD. |
| K090889 | EMSI GARMENT ELECTRODES | Dec 04, 2009 | Substantially Equivalent | EMSI |
| K093183 | BIS QUATRO SENSOR | Oct 23, 2009 | Substantially Equivalent | ASPECT MEDICAL SYSTEMS, INC. |
| K083758 | SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS | Aug 14, 2009 | Substantially Equivalent | THE ELECTRODE STORE, INC. |
| K083302 | LIFECARE ELECTRODES | Aug 03, 2009 | Substantially Equivalent | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
| K091163 | PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST | Jul 22, 2009 | Substantially Equivalent | FIAB SPA |
| K091854 | BIS CLICK SENSOR/CABLE | Jul 02, 2009 | Substantially Equivalent | ASPECT MEDICAL SYSTEMS, INC. |
| K083756 | GUARDIAN 150 ELECTRODE | Jun 26, 2009 | Substantially Equivalent | SELECTIVE MED COMPONENTS, INC. |
| K090198 | JIAJIAN SELF-ADHESIVE ELECTRODE | Jun 23, 2009 | Substantially Equivalent | WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. |
| K090951 | RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBG | Jun 05, 2009 | Substantially Equivalent | RS MEDICAL |
| K083441 | FREEDOM STIM 100 AND 200 ELECTRODE AND LEADWIRE EXTENSION | May 22, 2009 | Substantially Equivalent | MOTION MEDICAL PRODUCTS LLC |
| K083350 | TENS/NMES/FES STIMULATING ELECTRODE | Apr 21, 2009 | Substantially Equivalent | COVIDIEN LP |
| K082065 | WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP | Apr 10, 2009 | Substantially Equivalent | WELL-LIFE HEALTHCARE LIMITED |
| K081279 | PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000 | Jan 23, 2009 | Substantially Equivalent | TRANSFER TECHNOLOGY |
| K083818 | UNIVERSAL ELECTRODES | Jan 21, 2009 | Substantially Equivalent | NEUROMETRIX, INC. |
| K082540 | GE ENTROPY SENSOR | Nov 28, 2008 | Substantially Equivalent | GE HEALTHCARE |
| K081871 | UNIVERSAL ELECTRODES | Sep 29, 2008 | Substantially Equivalent | NEUROMETRIX, INC. |
| K080298 | DERMABIOSAFE | Aug 05, 2008 | Substantially Equivalent | COMPLETE PRODUCT RESOURCES |
| K080276 | SELF-ADHESIVE ELECTRODES | Aug 04, 2008 | Substantially Equivalent | CATHAY HEALTHCARE EQUIPMENT MANUFACTURING, INC |
| K071446 | ELECTRODE ARRAY CAP | Jul 02, 2008 | Substantially Equivalent | ELECTRODE ARRAYS |
| K080902 | FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058 | Jun 13, 2008 | Substantially Equivalent | LORENZ BIOTECH S.P.A. |
| K080386 | COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE | May 30, 2008 | Substantially Equivalent | COLUMBIA SCIENTIFIC DEVELOPMENT LLC |
| K073532 | DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES | May 01, 2008 | Substantially Equivalent | TECHNOMED EUROPE |
| K072799 | TARGET STERILE ELECTRODE | Apr 24, 2008 | Substantially Equivalent | VISION QUEST INDUSTRIES, INC. |
| K062580 | GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784) | Dec 21, 2007 | Substantially Equivalent | GE HEALTHCARE |
| K072016 | CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE | Oct 19, 2007 | Substantially Equivalent | TECHNOMED EUROPE |
| K071118 | GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE | Sep 07, 2007 | Substantially Equivalent | IVES EEG SOLUTIONS, INC. |
| K070807 | CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODES | May 23, 2007 | Substantially Equivalent | PEPIN MFG., INC. |
| K070612 | TOP-RANK ADHESIVE ELECTRODE | May 07, 2007 | Substantially Equivalent | TOP-RANK HEALTH CARE EQUIPMENT CO., LTD. |
| K070069 | ZIPPREP ELECTRODE | Feb 05, 2007 | Substantially Equivalent | ASPECT MEDICAL SYSTEMS, INC. |
| K062675 | GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES | Jan 04, 2007 | Substantially Equivalent | GEMORE TECHNOLOGY CO., LTD. |
| K062198 | SUNSPOTS PRE-GELLED SURFACE ELECTRODES | Dec 19, 2006 | Substantially Equivalent | AXON SYSTEMS, INC. |
| K062692 | BIS BILATERAL SENSOR | Dec 13, 2006 | Substantially Equivalent | ASPECT MEDICAL SYSTEMS, INC. |
| K063402 | WICK ELECTRODE, MODEL M019260 | Dec 11, 2006 | Substantially Equivalent | INTELLIGENT HEARING SYSTEMS |
| K061269 | XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES | Aug 14, 2006 | Substantially Equivalent | EXCEL TECH. LTD. |
| K061343 | INSPIRSTAR GLOVE ELECTRODE | May 31, 2006 | Substantially Equivalent | INSPIRSTAR, INC. |
| K061148 | RHYTHMLINK DISC ELECTRODES | May 10, 2006 | Substantially Equivalent | RHYTHMLINK INTERNATIONAL, LLC |
| K053626 | INTERX500 FLEXIBLE ARRAY ELECTRODE | Mar 29, 2006 | Substantially Equivalent | NEURO RESOURCE GROUP, INC. |
| K052875 | PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES | Dec 27, 2005 | Substantially Equivalent | SUMMIT MANUFACTURING, L.L.C. |
| K053214 | THERAKNIT GARMENT ELECTRODE | Dec 20, 2005 | Substantially Equivalent | NEUROTRON MEDICAL |
| K052188 | CUTANEOUS ELECTRODE | Aug 23, 2005 | Substantially Equivalent | RHYTHMLINK INTERNATIONAL, LLC |
| K051529 | AMBU NEUROLINE GROUND | Aug 04, 2005 | Substantially Equivalent | AMBU, INC. |
| K050788 | EVERLIFE | May 13, 2005 | Substantially Equivalent | EVERLIFE MEDICAL INSTRUMENT CO., LTD. |
| K050469 | EZ-STIK ELECTRODES | May 13, 2005 | Substantially Equivalent | NAIMCO, INC. |
| K043009 | BRAINET KIT | Jan 12, 2005 | Substantially Equivalent | JORDAN NEUROSCIENCE, INC. |
| K041902 | MANTRA ELECTRODE | Sep 22, 2004 | Substantially Equivalent | MANTRA INTL. (HK) LTD. |
| K042301 | PROTENS ELECTRODE | Sep 03, 2004 | Substantially Equivalent | BIO PROTECH, INC. |
| K041953 | VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART | Aug 09, 2004 | Substantially Equivalent | CONMED CORP. |
| K041670 | BIS PEDIATRIC SENSOR | Jul 06, 2004 | Substantially Equivalent | ASPECT MEDICAL SYSTEMS, INC. |
| K032278 | AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE | Mar 05, 2004 | Substantially Equivalent | AMBU, INC. |
| K032833 | MYOSYSTEM WITH CUSTOMIZING | Sep 23, 2003 | Substantially Equivalent | OTTO BOCK HEALTH CARE, LP |
| K030564 | THERMOSKIN CONDUCTIVE PADS | Sep 12, 2003 | Substantially Equivalent | UNITED PACIFIC, INC. |
| K030800 | ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES | Jun 11, 2003 | Substantially Equivalent | ELETROMED, INC. |
| K030375 | SOFT-TOUCH TENS ELECTRODE | May 05, 2003 | Substantially Equivalent | PAIN MANAGEMENT TECHNOLOGIES |
| K030297 | FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 | Apr 28, 2003 | Substantially Equivalent | ENRAF-NONIUS B.V. |
| K022917 | HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES | Mar 04, 2003 | Substantially Equivalent | HOME CARE TECHNOLOGY CO., LTD. |
| K021537 | MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005 | Mar 03, 2003 | Substantially Equivalent | VERMONT MEDICAL, INC. |
| K023212 | AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS | Dec 13, 2002 | Substantially Equivalent | AG GARMENTS |
| K020670 | MODEL 4310 PSARRAY2 EEG ELECTRODE | Oct 08, 2002 | Substantially Equivalent | PHYSIOMETRIX, INC. |
| K020903 | DOCXS B SERIES ELECTRODES | Sep 26, 2002 | Substantially Equivalent | DOCXS, LLC |
| K021986 | BRAINET | Aug 23, 2002 | Substantially Equivalent | NICOLET BIOMEDICAL, INC. |
| K022197 | SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY | Aug 13, 2002 | Substantially Equivalent | THE ELECTRODE STORE, INC. |
| K020735 | SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES | Jul 12, 2002 | Substantially Equivalent | CATHAY INTERNATIONAL, LTD. |
| K020445 | THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG | May 10, 2002 | Substantially Equivalent | THE ELECTRODE STORE, INC. |
| K003896 | LYMPHA VISION-EXPERT | Apr 24, 2002 | Substantially Equivalent | BEXLEY TRADING, INC. |
| K020468 | CHIN ELECTRODE | Apr 16, 2002 | Substantially Equivalent | DYMEDIX, INC. |
| K012463 | LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL | Feb 05, 2002 | Substantially Equivalent | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
| K011691 | KIMSTIM AURICULAR ELECTRODE | Dec 27, 2001 | Substantially Equivalent | KIM INSTITUTE FOR REHABILITATION MEDICINE, P.C. |
| K013813 | MODIFICATION TO:APEX MEDICAL IF-4100 | Dec 14, 2001 | Substantially Equivalent | APEX MEDICAL CORP. |
| K012140 | COM-PATCH | Oct 05, 2001 | Substantially Equivalent | APEX MEDICAL CORP. |
| K010431 | LEAD-LOK REUSABLE TENS/ NMES ELECTRODES | Sep 06, 2001 | Substantially Equivalent | LEAD-LOK, INC. |
| K011411 | SELF-ADHESIVE ELECTRODES | Jun 13, 2001 | Substantially Equivalent | PAIN MANAGEMENT TECHNOLOGIES |
| K010543 | KM-30 TENS ELECTRODE | May 23, 2001 | Substantially Equivalent | KATECHO, INC. |
| K010638 | NEUROPLUS, MODEL A10040, A10041, A10042, A10043 | May 03, 2001 | Substantially Equivalent | VERMONT MEDICAL, INC. |
| K002227 | WANDY SILICONE CONDUCTIVE RUBBER PAD | Feb 02, 2001 | Substantially Equivalent | WANDY RUBBER INDUSTRIAL CO., LTD |
| K002219 | WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE | Feb 02, 2001 | Substantially Equivalent | WANDY RUBBER INDUSTRIAL CO., LTD |
| K001521 | SOFTSENS | Nov 27, 2000 | Substantially Equivalent | INTEGRATED BIOSENSING TECHNOLOGIES |
| K000870 | KM-10 TENS ELECTRODE | Nov 07, 2000 | Substantially Equivalent | KATECHO, INC. |
| K001980 | ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110 | Sep 27, 2000 | Substantially Equivalent | ASPECT MEDICAL SYSTEMS, INC. |
| K002734 | ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 | Sep 14, 2000 | Substantially Equivalent | ASPECT MEDICAL SYSTEMS, INC. |
| K001117 | COMFORT STIM | Jul 05, 2000 | Substantially Equivalent | R & D MEDICAL PRODUCTS, INC. |
| K000947 | ULTRASTIM ELECTRODE, MODEL US4040 | Jun 16, 2000 | Substantially Equivalent | AXELGAARD MFG. CO., LTD. |
| K001055 | MODEL 4300 PSARRAY EEG ELECTRODE SET | May 11, 2000 | Substantially Equivalent | PHYSIOMETRIX, INC. |
| K000865 | QUIK-CAP | Apr 18, 2000 | Substantially Equivalent | NEUROSCAN |
| K994330 | ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076 | Jan 18, 2000 | Substantially Equivalent | ASPECT MEDICAL SYSTEMS, INC. |
| K993130 | ULTRA-GARMENT ELECTRODE | Dec 17, 1999 | Substantially Equivalent | NEWWAVE MEDICAL LLC. |
| K983097 | TENS/FES/NMES ELECTRODES | Sep 17, 1999 | Substantially Equivalent | UNI-PATCH, INC. |
| K991772 | CUTANEOUS (DISC) ELECTRODE | Aug 18, 1999 | Substantially Equivalent | NEURO SUPPLIES, INC. |
| K991771 | DIGITAL RING ELECTRDE | Aug 18, 1999 | Substantially Equivalent | NEURO SUPPLIES, INC. |
| K991770 | CUTANEOUS (GROUND) ELECTRODE | Aug 18, 1999 | Substantially Equivalent | NEURO SUPPLIES, INC. |
| K991769 | CUTANEOUS (BAR) ELECTRODE | Aug 18, 1999 | Substantially Equivalent | NEURO SUPPLIES, INC. |
| K991199 | BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150 | Jun 22, 1999 | Substantially Equivalent | BIOMED PRODUCTS |
| K982096 | DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO | Jun 18, 1999 | Substantially Equivalent | RAPID MFG. CO. |
| K982053 | EEG ELECTRODES MODEL 445 SERIES | Apr 20, 1999 | Substantially Equivalent | CLASS A ENT. |
| K990370 | MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES) | Apr 12, 1999 | Substantially Equivalent | MSB,UK |
| K983741 | EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020 | Dec 18, 1998 | Substantially Equivalent | AXELGAARD MFG. CO., LTD. |
| K980410 | SLE ELECTRODES AND ACCESSORIES | Oct 22, 1998 | Substantially Equivalent | SPECIALIZED LABORATORY EQUIPMENT, LTD. |
| K971914 | TECA NCS ELECTRODE SYSTEM 2000 | Mar 26, 1998 | Substantially Equivalent | MEDELEC, INC. D.B.A. TECA CORP. |
| K980229 | MSB TENS ELECTRODES (DISPOSABLE) | Feb 27, 1998 | Substantially Equivalent | MSB LTD. |
| K972122 | DREAM CATCHER | Aug 29, 1997 | Substantially Equivalent | REST TECHNOLOGIES, INC. |
| K970639 | NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K | May 15, 1997 | Substantially Equivalent | MEDICOTEST, INC. |
| K970426 | VALUETRODE | May 09, 1997 | Substantially Equivalent | AXELGAARD MFG. CO., LTD. |
| K965194 | MEDICOM, TENS ELECTRODES | Mar 06, 1997 | Substantially Equivalent | MEDICOTEST A/S |
| K964433 | AQUABOND ELECTRODE | Jan 27, 1997 | Substantially Equivalent | MEDIBOND LTD. |
| K962283 | EEG ELECTRODES | Dec 16, 1996 | Substantially Equivalent | TECA, INC. |
| K963236 | M & R DISPOSABLE ELECTRODE (14200) | Nov 15, 1996 | Substantially Equivalent | M & R MFG., INC. |
| K961821 | ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR | Oct 04, 1996 | Substantially Equivalent | ASPECT MEDICAL SYSTEMS, INC. |
| K961609 | MODEL 1220, OR E-NET (54-62 CM) | May 10, 1996 | Substantially Equivalent | PHYSIOMETRIX, INC. |
| K961141 | EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220 | May 10, 1996 | Substantially Equivalent | UNI-PATCH, INC. |
| K960885 | MODEL 1240, SMALL E NET | Apr 26, 1996 | Substantially Equivalent | PHYSIOMETRIX, INC. |
| K960873 | MODEL 1210, MEDIUM E-NET | Apr 26, 1996 | Substantially Equivalent | PHYSIOMETRIX, INC. |
| K960732 | HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500 | Apr 15, 1996 | Substantially Equivalent | PHYSIOMETRIX, INC. |
| K953361 | EMG DISC RECORDING ELECTRODE | Jan 22, 1996 | Substantially Equivalent | CHALGREN ENTERPRISES, INC. |
| K953356 | EMG RECORDING RING ELECTRODE | Jan 22, 1996 | Substantially Equivalent | CHALGREN ENTERPRISES, INC. |
| K953354 | EMG DISC RECORDING ELECTRODE | Jan 22, 1996 | Substantially Equivalent | CHALGREN ENTERPRISES, INC. |
| K944314 | DISPOSABLE TM-E COCHGTRODE - BLSC PART NO. 101123 | Jan 03, 1996 | Substantially Equivalent | BIO-LOGIC SYSTEMS CORP. |
| K952908 | EMG DISC RECORDING ELECTRODE WITH PIN | Dec 06, 1995 | Substantially Equivalent | CHALGREN ENTERPRISES, INC. |
| K952690 | EMG DISC RECORDING ELECTRODE WITH PIN | Dec 06, 1995 | Substantially Equivalent | CHALGREN ENTERPRISES, INC. |
| K943449 | NEUROLOGICAL DIAGNOSTIC DEVICES | Nov 15, 1995 | Substantially Equivalent | HENLEY INTL. |
| K953220 | 32MM NICKEL PLATED DISC ELECTRODE | Oct 06, 1995 | Substantially Equivalent | CHALGREN ENTERPRISES, INC. |
| K953219 | 22MM STAINLESS STEEL DISC ELECTRODE, WITH PIN | Oct 06, 1995 | Substantially Equivalent | CHALGREN ENTERPRISES, INC. |
| K952176 | DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-K | Sep 25, 1995 | Substantially Equivalent | MEDICOTEST, INC. |
| K944543 | BIOFLEX GARMENTS, ASSORTED MODELS | Jul 19, 1995 | Substantially Equivalent | BIOFLEX, INC. |
| K950782 | MEDI-TRAC EEG ELECTRODE | Jun 22, 1995 | Substantially Equivalent | GRAPHIC CONTROLS CORP. |
| K946318 | MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE | Apr 24, 1995 | Substantially Equivalent | PHYSIOMETRIX, INC. |
| K950491 | RICH-MAR CARBON ELECTRODES | Mar 29, 1995 | Substantially Equivalent | RICH-MAR CORP. |
| K944487 | ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES | Feb 21, 1995 | Substantially Equivalent | PRIZM MEDICAL, INC. |
| K943009 | SMD ELECTRODES | Feb 21, 1995 | Substantially Equivalent | SCIENTIFIC MEDICAL DEVICES, INC. |
| K941986 | CUTANEOUS ELECTRODE | Feb 21, 1995 | Substantially Equivalent | MAXXIM MEDICAL |
| K941799 | DISPOSABLE CUTANEOUS ELECTRODES | Feb 03, 1995 | Substantially Equivalent | BIO-LOGIC SYSTEMS CORP. |
| K942921 | NEUROLINK EEG/EP/EMG SURFACE ELECTRODES | Jan 31, 1995 | Substantially Equivalent | NEURO SUPPLIES, INC. |
| K933808 | EEG CUP ELECTRODE | Dec 29, 1994 | Substantially Equivalent | CADWELL LABORATORIES, INC. |
| K933805 | RING ELECTRODE | Dec 19, 1994 | Substantially Equivalent | CADWELL LABORATORIES, INC. |
| K944603 | CONMED VERSA STEM NEUROMUSCULAR STIMULATION/TENS | Dec 15, 1994 | Substantially Equivalent | CONMED CORP. |
| K943126 | ELECTROFLEX | Dec 05, 1994 | Substantially Equivalent | MEDICAL DEVICES, INC. |
| K940012 | SMARTBRACE ELECTRODE | Dec 05, 1994 | Substantially Equivalent | MEDICAL DEVICES, INC. |
| K941568 | K-10-VS, DA-05-VS, RECORDING ELECTRODES | Nov 04, 1994 | Substantially Equivalent | MEDICOTEST, INC. |
| K933801 | ELECTRODE, CUTANEOUS | Oct 21, 1994 | Substantially Equivalent | CADWELL LABORATORIES, INC. |
| K942461 | NEUROLOGY ACCESSORIES - MARK-EASY 10-20 | Oct 19, 1994 | Substantially Equivalent | OPTIMIT USA, INC. |
| K934580 | DANTEC 13R45 BAR ELECTRODE | Sep 26, 1994 | Substantially Equivalent | DANTEC MEDICAL, INC. |
| K942718 | CLOTH TENS/BNES ELECTRODE | Sep 22, 1994 | Substantially Equivalent | CONMED ANDOVER MEDICAL, INC. |
| K933802 | CUTANEOUS ELECTRODE | Sep 07, 1994 | Substantially Equivalent | CADWELL LABORATORIES, INC. |
| K933807 | GROUND PLATE ELECTRODE | Jul 26, 1994 | Substantially Equivalent | CADWELL LABORATORIES, INC. |
| K933803 | DISPOSABLE TAB ELECTRODE | Jul 08, 1994 | Substantially Equivalent | CADWELL LABORATORIES, INC. |
| K932299 | ELECTRO-MESH | Jul 01, 1994 | Substantially Equivalent | PRIZM MEDICAL, INC. |
| K936101 | CONMED VERSA-STIM NEUROMUSCULAR STIMULATION ELECTRODE | Jun 30, 1994 | Substantially Equivalent | CONMED CORP. |
| K940704 | CONMED VERSA-STIM INTERFERENTIAL ELECTRODE | Jun 22, 1994 | Substantially Equivalent | CONMED CORP. |
| K931430 | CUTANEOUS ELECTRODE | Dec 21, 1993 | Substantially Equivalent | MEDICOTEST, INC. |
| K931426 | NF-11-E DISPOSABLE REFERENCE/RECORDING ELECTRODE | Dec 21, 1993 | Substantially Equivalent | MEDICOTEST, INC. |
| K933814 | PHOTOSTRESS RECOVERY TESTER | Dec 08, 1993 | Substantially Equivalent | STORZ INSTRUMENT CO. |
| K931925 | TPK CUTANEOUS ELECTRODE | Aug 16, 1993 | Substantially Equivalent | STAODYNE, INC. |
| K922393 | EMITENS ELECTRODES | Jul 21, 1993 | Substantially Equivalent | ELECTRONIC MONITORS, INC. |
| K915864 | MONOTRODE CUTANEOUS ELECTRODE | Jul 21, 1993 | Substantially Equivalent | HENLEY INTL. |
| K924473 | DISPOSABLE THERAPY ELECTRODE | May 19, 1993 | Substantially Equivalent | ZIMMER ELEKTROMEDIZIN GMBH |
| K925706 | REUSABLE FINGER CLIP RECORDING ELECTRODE | Feb 10, 1993 | Substantially Equivalent | CHALGREN ENTERPRISES, INC. |
| K920674 | ELECTROLINK | Jan 28, 1993 | Substantially Equivalent | KOLD PRODUCTS |
| K912210 | PRO-CHILL STIMPACK | Nov 27, 1992 | Substantially Equivalent | TKO, INC. |
| K920264 | BIO-DETEK TRACERITE EEG ELECTRODE | Jun 02, 1992 | Substantially Equivalent | BIO-DETEK, INC. |
| K912643 | ELECTRODE | Feb 14, 1992 | Substantially Equivalent | SKYLARK DEVICE CO., LTD. |
| K913031 | K-STIM | Jan 30, 1992 | Substantially Equivalent | KATECHO, INC. |
| K915333 | ELECTRODE USING PROMEON RG-60 SERIES GEL | Jan 14, 1992 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K914384 | MEDICAL DESIGNS REUSABLE CARBON RUBBER ELECTRODE | Nov 13, 1991 | Substantially Equivalent | MEDICAL DESIGN & MANUFACTURING CORP. |
| K911366 | PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE | Sep 27, 1991 | Substantially Equivalent | MEDICAL DESIGN & MANUFACTURING CORP. |
| K913373 | GLOBALCARE ELECTRODE | Aug 29, 1991 | Substantially Equivalent | GLOBALCARE INTL., INC. |
| K911989 | GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT. | Jul 30, 1991 | Substantially Equivalent | SOMNITEC, INC. |
| K911069 | VERSA-STIM ELECTRODE LINE MODIFIED | Jul 16, 1991 | Substantially Equivalent | CONMED CORP. |
| K905539 | 3M 6830 ELECTRODE | May 28, 1991 | Substantially Equivalent | 3M HEALTH CARE |
| K903554 | NORTECH MODEL 87202204 ELECTRODE | Aug 30, 1990 | Substantially Equivalent | MEDTRONIC ANDOVER MEDICAL, INC. |
| K903402 | GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L | Aug 22, 1990 | Substantially Equivalent | MEDI-SOURCE, INC. |
| K903427 | NORTECH MODEL 86901000 ELECTRODE | Aug 17, 1990 | Substantially Equivalent | ANDOVER MEDICAL, INC. |
| K902719 | SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT | Jul 19, 1990 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K901809 | LUMISCOPE ELECTRODES MODELS EL-08,11,15,06,21,25 | Jun 18, 1990 | Substantially Equivalent | LUMISCOPE CO., INC. |
| K902195 | TBD TENS REUSABLE ELECTRODE | Jun 08, 1990 | Substantially Equivalent | EMPI |
| K901575 | REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD | May 02, 1990 | Substantially Equivalent | PIONEERING TECHNOLOGIES, INC. |
| K900825 | 'POLYSTIM' | Apr 10, 1990 | Substantially Equivalent | MEDICAL SCIENCE PRODUCTS, INC. |
| K901103 | MODIFIED ISLAND SNAP TENS DISPOSABLE ELECTRODE | Mar 23, 1990 | Substantially Equivalent | EMPI |
| K901102 | MODIFIED ISLAND PIN TENS DISPOSABLE ELECTRODE | Mar 23, 1990 | Substantially Equivalent | EMPI |
| K896766 | TD-28 DISPOSABLE ELECTRODE | Mar 14, 1990 | Substantially Equivalent | MED USA |
| K900997 | K-STERILE TENS ELECTRODES | Mar 13, 1990 | Substantially Equivalent | KATECHO, INC. |
| K900606 | 'CONDUCTOR' DISPOSABLE TENS ELECTRODE | Mar 13, 1990 | Substantially Equivalent | MEDICAL SCIENCE PRODUCTS, INC. |
| K900656 | SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT. | Mar 01, 1990 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K900059 | BIOPOTENTIAL SURFACE ELECTRODE | Feb 22, 1990 | Substantially Equivalent | INTEGRAL DESIGN, INC. |
| K896844 | BABE-EASE NEONATAL CLOTH ECG ELECTRODE | Feb 12, 1990 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K896936 | L.A.S.P. LUMBAR AND SACRAL PAD, REPOSITION. SNAP | Jan 22, 1990 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K896485 | MODIFIED ISLAND TENS DISP. ELECTRODE FOR SNAP CONN | Dec 21, 1989 | Substantially Equivalent | EMPI |
| K893793 | TENZCARE ELECTRODE 6862 | Nov 27, 1989 | Substantially Equivalent | 3M COMPANY |
| K895081 | PROMONTORY STIMULATING ELECTRODE | Nov 09, 1989 | Substantially Equivalent | CADWELL LABORATORIES, INC. |
| K890981 | ELECTRO-TOUCH (ET) GLOVE | Oct 19, 1989 | Substantially Equivalent | PSYCHOENERGETIC SYSTEMS, INC. |
| K895604 | SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES | Oct 13, 1989 | Substantially Equivalent | MEDICAL DESIGN & MANUFACTURING CORP. |
| K894043 | SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS | Aug 11, 1989 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K894042 | SPECT.E.N.S. REPOSITIONABLE, PIN TYPE, TENS | Aug 11, 1989 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K891107 | INDICATENS INDICATOR ELECTRODE MODEL 2 | May 25, 1989 | Substantially Equivalent | ACUDATA SOFTWARE |
| K891105 | INDICATENS MODEL 4X4 SP ELECTRODE STIM. PATCHES | May 25, 1989 | Substantially Equivalent | ACUDATA SOFTWARE |
| K890747 | EMPI REUSEABLE PIN-STYLE TENS ELECTRODE | Mar 16, 1989 | Substantially Equivalent | EMPI |
| K890614 | EMPI MULTIDAY TENS DISPOSABLE ELECTRODE | Mar 16, 1989 | Substantially Equivalent | EMPI |
| K890605 | EMPI ISLAND TENS ELECTRODE | Mar 16, 1989 | Substantially Equivalent | EMPI |
| K890710 | DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS | Mar 14, 1989 | Substantially Equivalent | SOMATICS, INC. |
| K884814 | BIOTENS | Feb 27, 1989 | Substantially Equivalent | TREKK INTL. |
| K884348 | MODIFIED JELTRODE(TM) ELECTRODES DEEMED | Dec 15, 1988 | Substantially Equivalent | HENLEY INTL. |
| K882464 | DTL MICROTOUCH EYE ELECTRODE | Nov 15, 1988 | Substantially Equivalent | LECTROMEDICS, INC. |
| K882888 | MULTIDAY, MODELS 8300 AND 8310 | Sep 30, 1988 | Substantially Equivalent | MEDICAL DEVICES, INC. |
| K882887 | PROGEL(TM), MODELS 8630 AND 8635 | Sep 29, 1988 | Substantially Equivalent | MEDICAL DEVICES, INC. |
| K882886 | PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535 | Sep 29, 1988 | Substantially Equivalent | MEDICAL DEVICES, INC. |
| K882809 | THYMAPAD | Sep 27, 1988 | Substantially Equivalent | SOMATICS, INC. |
| K881749 | STRAIGHT-LINE FINISH FOR IMPLANTABLE PULSE GENERA. | Jul 18, 1988 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K881872 | TENS ELECTRODE MODEL 238P | Jun 16, 1988 | Substantially Equivalent | LECTEC CORP. |
| K881871 | SPARE MS 700 TENS ELECTRODE | Jun 16, 1988 | Substantially Equivalent | LECTEC CORP. |
| K881444 | T.E.N.S. ELECTRODE NON-STERILE | Jun 10, 1988 | Substantially Equivalent | TENS ACCESSORIES, INC. |
| K880545 | STIMWEAR GARMENTS, SIGNAL I AND SIGNAL II | May 31, 1988 | Substantially Equivalent | STIMWEAR |
| K881343 | DURADERM BUTTERFLY | May 04, 1988 | Substantially Equivalent | SENTRY MEDICAL PRODUCTS, INC. |
| K880649 | TENS ELECTRODE SNAP TYPE, DISPOSA., SELF-ADHERING | Mar 04, 1988 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K875284 | MEDTRONIC SNAP EASE MODEL 7795 CUTANEOUS ELECTRODE | Jan 28, 1988 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K874469 | TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) | Jan 28, 1988 | Substantially Equivalent | AXELGAARD MFG. CO., LTD. |
| K874735 | DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE | Jan 22, 1988 | Substantially Equivalent | DANTEC ELECTRONICS, INC. |
| K873298 | ELEC-TIP | Nov 24, 1987 | Substantially Equivalent | ETYMOTIC RESEARCH |
| K874075 | PT-100-30 SOMATOSENSORY STIMULATING ELECTRODE | Oct 20, 1987 | Substantially Equivalent | WEAVER & CO. |
| K872976 | TENS PALS PLUS | Sep 22, 1987 | Substantially Equivalent | AXELGAARD MFG. CO., LTD. |
| K872250 | LECTEC STIMULATING ELECTRODE | Aug 07, 1987 | Substantially Equivalent | LECTEC CORP. |
| K872574 | TENSAGAIN | Jul 23, 1987 | Substantially Equivalent | FERRIS MFG. CORP. |
| K872492 | ALTERNATE SUPPLIERS FOR TENS ELECTRODE | Jul 22, 1987 | Substantially Equivalent | FRANKLIN SALES & MFG. CO. |
| K872044 | CARBON ELECTRODE | Jul 16, 1987 | Substantially Equivalent | FUTUREMED DIV. OF FUTURE IMPEX CORP. |
| K871292 | HEALTH CONCEPTS CONDUCTIVE MEMBRANE | Jun 02, 1987 | Substantially Equivalent | HEALTH CONCEPTS, INC. |
| K871222 | TANTONE MULTI-DAY #633 TENS ELECTRODE | May 29, 1987 | Substantially Equivalent | UNI-PATCH, INC. |
| K871026 | DISPOSABLE, PIN-CONN. POLYMER-GEL ELECT. FOR TENS | Apr 22, 1987 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K870160 | DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENS | Apr 01, 1987 | Substantially Equivalent | LA JOLLA TECHNOLOGY, INC. |
| K864973 | TENZCARE(TM) SNAP ELECTRODE 6867 | Jan 20, 1987 | Substantially Equivalent | 3M COMPANY |
| K864032 | EM TENS WINDOW ELECTRODES | Dec 22, 1986 | Substantially Equivalent | ELECTROMED INTL., LTD. |
| K862377 | QMED SELF ADHERING ELECTRODE | Sep 26, 1986 | Substantially Equivalent | QMED, INC. |
| K863307 | TENZCARE SNAP ELECTRODE, NO. 6865 | Sep 23, 1986 | Substantially Equivalent | 3M COMPANY |
| K863035 | POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER | Sep 18, 1986 | Substantially Equivalent | VALLEYLAB, INC. |
| K862718 | VERSA STIM | Sep 09, 1986 | Substantially Equivalent | CONMED CORP. |
| K862231 | EMPI, MODEL 1000 HAND HELD ELECTRODE | Aug 27, 1986 | Substantially Equivalent | EMPI |
| K862028 | ULTRAHESIVE II POSTOP ELECTRODE | Aug 01, 1986 | Substantially Equivalent | MEDICAL DEVICES, INC. |
| K862011 | MULTI-DAY ELECTRODES | Jul 03, 1986 | Substantially Equivalent | MEDICAL ELECTRONIC ASSN. |
| K861956 | JELTRODE | Jun 26, 1986 | Substantially Equivalent | HENLEY INTL. |
| K854204 | DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS | Jan 10, 1986 | Substantially Equivalent | LA JOLLA TECHNOLOGY, INC. |
| K854513 | EMPI, NMS/SUE CUTANEOUS ELECTRODE | Dec 06, 1985 | Substantially Equivalent | EMPI |
| K853633 | TENS CONDUCTIVE MEDIA PAD | Dec 03, 1985 | Substantially Equivalent | ALTERNATIVE DESIGN SYSTEMS, INC. |
| K853552 | SENTRY FLEXIBLE TENS | Sep 26, 1985 | Substantially Equivalent | SENTRY MEDICAL PRODUCTS, INC. |
| K850646 | ECLIPSE SELF ADHERING ELECTRODE | Sep 03, 1985 | Substantially Equivalent | TODD MEDICAL, INC. |
| K852298 | TENS-AID STERILE ELECTRODES FOR POST-OP TENS | Jun 24, 1985 | Substantially Equivalent | STAODYNAMICS, INC. |
| K852267 | ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES | Jun 18, 1985 | Substantially Equivalent | AXELGAARD MFG. CO., LTD. |
| K851175 | TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE | Jun 18, 1985 | Substantially Equivalent | MEDICAL DEVICES, INC. |
| K851303 | COMFORT-EASE ELECTRODE | May 23, 1985 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K850108 | EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG | Apr 11, 1985 | Substantially Equivalent | NICOLET BIOMEDICAL INSTRUMENTS |
| K850311 | DISPOS. CONDUCTIVE ADHESIVE TENS PAD | Mar 05, 1985 | Substantially Equivalent | CONSOLIDATED MEDICAL EQUIPMENT, INC. |
| K850131 | CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS | Mar 05, 1985 | Substantially Equivalent | CONSOLIDATED MEDICAL EQUIPMENT, INC. |
| K843964 | TENS-AID PREMIUM ELECTRODES | Feb 25, 1985 | Substantially Equivalent | STAODYNAMICS, INC. |
| K844098 | CANMED 103 | Feb 04, 1985 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K844023 | AQUAFORM ELECTRODES WITH AQUAPORE | Feb 01, 1985 | Substantially Equivalent | BIOSTIM, INC. |
| K844646 | SIEGEN SURFACE ELECTRODES | Dec 11, 1984 | Substantially Equivalent | SIEGEN CORP. |
| K844097 | CANMED 103 9300 ELECTRODE | Dec 11, 1984 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K842033 | ELECTRODE PLACEMENT ARM PART GARMENT | Jul 26, 1984 | Substantially Equivalent | BIO-STIMU TREND CORP. |
| K842271 | ELECTRODE, SURFACE EEG ELECTRODE | Jul 20, 1984 | Substantially Equivalent | DURDEN ENTERPRISES, INC. |
| K841877 | EEG ELECTRODE PAD | Jul 19, 1984 | Substantially Equivalent | NEUROLOGICS, INC. |
| K841685 | EEG ELECTRODES | Jun 07, 1984 | Substantially Equivalent | BIO-SCAN, INC. |
| K840396 | ELECTRO-MESH WRAP | Apr 30, 1984 | Substantially Equivalent | WHITING & DAVIS CO. |
| K840395 | ELECTRO-MESH GLOVE | Apr 30, 1984 | Substantially Equivalent | WHITING & DAVIS CO. |
| K840592 | ELECTRODE PLACEMENT LUMBAR SHORTS | Mar 23, 1984 | Substantially Equivalent | BIO-STIMU TREND CORP. |
| K840591 | ELECTRODE PLACEMENT SLEEVE | Mar 23, 1984 | Substantially Equivalent | BIO-STIMU TREND CORP. |
| K832296 | S2 POSTERIOR-TIB | Aug 31, 1983 | Substantially Equivalent | ANSTEK CORP. |
| K832295 | S2MEDIAN | Aug 31, 1983 | Substantially Equivalent | ANSTEK CORP. |
| K832145 | MONOBLOCK PROSTOPERATIVE TENS ELECTRODE | Jul 19, 1983 | Substantially Equivalent | NEW DIMENSIONS IN MEDICINE, INC. |
| K831785 | NEURO EASE | Jun 30, 1983 | Substantially Equivalent | ANDOVER MEDICAL, INC. |
| K831104 | TENZCARE MUSCLE STIMULATION ELECTRODES | May 09, 1983 | Substantially Equivalent | 3M COMPANY |
| K831046 | ELECTRODE 3799 | Apr 26, 1983 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K830798 | STERILE SURGICAL PAIN RELIEF ELECTRODE | Apr 05, 1983 | Substantially Equivalent | LECTEC CORP. |
| K830602 | PRECISION CAP STRAPS | Mar 24, 1983 | Substantially Equivalent | PRECISION CAP SYSTEMS |
| K830601 | FOAMIES DIAPOS. FOAM RUBBER PADS | Mar 24, 1983 | Substantially Equivalent | PRECISION CAP SYSTEMS |
| K830600 | REFERENCE & MONITORING ELECTRODE | Mar 24, 1983 | Substantially Equivalent | PRECISION CAP SYSTEMS |
| K830599 | LOCALIZING ELECTRODE | Mar 24, 1983 | Substantially Equivalent | PRECISION CAP SYSTEMS |
| K830598 | EVOKED POTENTIAL CAP W/EVOKED POTENTIAL | Mar 24, 1983 | Substantially Equivalent | PRECISION CAP SYSTEMS |
| K830597 | BABY CAP, ELECTRODE SET & BOARD ADAPTOR | Mar 24, 1983 | Substantially Equivalent | PRECISION CAP SYSTEMS |
| K830521 | PRECISION EEG CAP W/ELECTRODE SET AND | Mar 24, 1983 | Substantially Equivalent | PRECISION CAP SYSTEMS |
| K822378 | TENS ELECTRODE | Aug 24, 1982 | Substantially Equivalent | FRANKLIN SALES & MFG. CO. |
| K822224 | EMPI SINGLE USE | Aug 16, 1982 | Substantially Equivalent | EMPI |
| K820876 | MODEL 3854 ELECTRODE | Apr 21, 1982 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K820082 | POST-OP ELECTRODE (TENS ELECTRODE) | Jan 28, 1982 | Substantially Equivalent | CONSOLIDATED MEDICAL EQUIPMENT, INC. |
| K812418 | MEDTRONIC #3798 ELECTRODE | Sep 16, 1981 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K812299 | ELECTRO-SNAP | Sep 11, 1981 | Substantially Equivalent | RODEL PRODUCTS CORP. |
| K810206 | DUAL TYPE ELECTRODE | Mar 20, 1981 | Substantially Equivalent | PROFESSIONAL INSTRUMENTS CO. |
| K810262 | AUTOMATIC ELECTRODE PLACEMENT BELT | Mar 11, 1981 | Substantially Equivalent | WALLANT INTL. TRADE, INC. |
| K803012 | SHUR-PATCH TAPE PATCH | Dec 30, 1980 | Substantially Equivalent | SHUR MEDICAL CORP. |
| K800117 | TRU-PULSE PADS | Feb 11, 1980 | Substantially Equivalent | IPCO CORP. |
| K792351 | MEDTRONIC MOD. 3852 STERIL-ICE ELECTRODE | Dec 05, 1979 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K791097 | CEPTORTRODE WITH CEPTOR HESIVE | Aug 03, 1979 | Substantially Equivalent | MED GENERAL |
| K790850 | T.E.N.S.* SINGLE-USE ELECTRODE | May 31, 1979 | Substantially Equivalent | 3M COMPANY |
| K790542 | ELECTRODES, STAODERM STERILE | May 23, 1979 | Substantially Equivalent | STAODYNAMICS, INC. |
| K790316 | ELECTRODE, ELECTROFLEX | Mar 27, 1979 | Substantially Equivalent | ANDOVER MEDICAL, INC. |
| K790345 | STIMTECH TENS ELECTRODE | Mar 21, 1979 | Substantially Equivalent | STIMULATION TECHNOLOGY, INC. |
| K790269 | CEPTOR HESIVE | Feb 26, 1979 | Substantially Equivalent | MED GENERAL |
| K782137 | MEDTRONIC MODEL 3797 ELECTRODE | Feb 07, 1979 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K781494 | EEG LEAD ASSEMBLY | Oct 31, 1978 | Substantially Equivalent | GRAPHIC CONTROLS CORP. |
| K781314 | THERAPY UNIT & ELECTRODIAG. | Oct 03, 1978 | Substantially Equivalent | GENERAL THERAPHYSICAL, INC. |
| K780537 | EAR ELECTRODE-ADULT & PEDIATRIC | Jun 02, 1978 | Substantially Equivalent | LIFE-TECH INSTRUMENTS, INC. |
| K780045 | ELECTRODE CAP | Jan 24, 1978 | Substantially Equivalent | ELECTRO-CAP INTL., INC. |
| K771719 | KARAYA ELECTRODES | Sep 20, 1977 | Substantially Equivalent | LECTEC CORP. |
| K770448 | INS - T.E.N.S. | Mar 15, 1977 | Substantially Equivalent | STIMULATION TECHNOLOGY, INC. |
| K770447 | EPC INSTICKS | Mar 15, 1977 | Substantially Equivalent | STIMULATION TECHNOLOGY, INC. |
| K770323 | VERI/TRODES | Feb 28, 1977 | Substantially Equivalent | VERITE SCIENTIFIC, INC. |
| K760947 | PREGELLED DISPOSABLE ELECTRODE | Nov 09, 1976 | Substantially Equivalent | TEXAS INSTRUMENTS, INC. |
| K760312 | ELECTRODE, PNS | Aug 04, 1976 | Substantially Equivalent | NDM CORP. |
FEI Numbers
This FDA classification entry is associated with 242 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 242 registration numbers. Click on an entry to view related FDA registrations.