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Electrode, Cutaneous

FDA product code GXY · 425 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.1320
Review panel: NE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-04 – 2026-08-27

GXY 2013-05-30

MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE

Applicant Rhythmlink International, LLC

K number K130287

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GXY 2013-04-24

DE48-PLUS

Applicant Grass Technologies, an Astro-Med, Inc. Product Gro

K number K123915

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GXY 2013-01-25

ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE

Applicant Eswallow USA

K number K113375

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GXY 2012-12-19

PMT TRUSCAN SURFACE ELECTRODE

Applicant Pmt Corp.

K number K122376

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GXY 2012-11-26

SENSUS ELECTRODE

Applicant Neurometrix, Inc.

K number K121816

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GXY 2012-10-15

REUSABLE CUTANEOUS ELECTRODE

Applicant Ampcare, LLC

K number K121483

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GXY 2012-08-20

DYNATRON THERMOSTIM PROBE-DONE

Applicant Dynatronics Corporation

K number K120835

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GXY 2012-06-11

DISPOSABLE ADHESIVE SURFACE ELECTRODE

Applicant Spes Medica Srl

K number K120494

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GXY 2012-05-17

LONG LIFE PADTM

Applicant Omron Healthcare, Inc.

K number K120516

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GXY 2012-01-27

ELECTRO-CAP SYSTEM

Applicant Electro-Cap Intl., Inc.

K number K112319

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GXY 2012-01-25

THERATRODE

Applicant Phoenix Medical Devices, Llp

K number K112312

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GXY 2012-01-20

NEUROTECH RECOVERY

Applicant Bio-Medical Research, Ltd.

K number K112934

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GXY 2011-10-14

DISPOSABLE ELECTRODE

Applicant Sanibel Supply

K number K111737

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GXY 2011-09-13

REUSABLE STIMULATING ELECTRODES

Applicant Bio Protech, Inc.

K number K111270

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GXY 2011-08-30

FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE

Applicant Xian Friendship Medical Electronics Co., Ltd.

K number K110289

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GXY 2011-08-24

LIFECARE CONDUCTIVE GARMENTS

Applicant Everyway Medical Instruments Co.,Ltd

K number K103719

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GXY 2011-06-29

WAVEGUARD (TM) EEG CAP

Applicant Eemagine Medical Imaging Solutions GmbH

K number K110223

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GXY 2011-06-03

AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40

Applicant Bio-Medical Research, Ltd.

K number K102614

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GXY 2010-12-02

ADHESIVE ELECTRODES

Applicant Reno Medical Limited

K number K102842

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GXY 2010-09-03

SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE

Applicant Covidien

K number K100418

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GXY 2010-01-29

STATNET, MODEL 3100

Applicant Hydrodot, Inc.

K number K092828

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GXY 2009-12-22

DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE

Applicant Covidien

K number K091762

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GXY 2009-12-18

GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM

Applicant Gmdasz Manufacturing Co., Ltd.

K number K092546

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GXY 2009-12-07

MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411

Applicant Bio-Medical Research, Ltd.

K number K092793

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GXY 2009-12-04

EMSI GARMENT ELECTRODES

Applicant Emsi

K number K090889

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GXY 2009-10-23

BIS QUATRO SENSOR

Applicant Aspect Medical Systems, Inc.

K number K093183

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GXY 2009-08-14

SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS

Applicant The Electrode Store, Inc.

K number K083758

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GXY 2009-08-03

LIFECARE ELECTRODES

Applicant Everyway Medical Instruments Co.,Ltd

K number K083302

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GXY 2009-07-22

PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST

Applicant Fiab Spa

K number K091163

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GXY 2009-07-02

BIS CLICK SENSOR/CABLE

Applicant Aspect Medical Systems, Inc.

K number K091854

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GXY 2009-06-26

GUARDIAN 150 ELECTRODE

Applicant Selectivemed Components, Inc.

K number K083756

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GXY 2009-06-23

JIAJIAN SELF-ADHESIVE ELECTRODE

Applicant Wuxi Jiajian Medical Instrument Co., Ltd.

K number K090198

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GXY 2009-06-05

RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBG

Applicant Rs Medical

K number K090951

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GXY 2009-05-22

FREEDOM STIM 100 AND 200 ELECTRODE AND LEADWIRE EXTENSION

Applicant Motion Medical Products, LLC

K number K083441

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GXY 2009-04-21

TENS/NMES/FES STIMULATING ELECTRODE

Applicant Covidien LP

K number K083350

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GXY 2009-04-10

WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP

Applicant Well-Life Healthcare Limited

K number K082065

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GXY 2009-01-23

PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000

Applicant Transfer Technology

K number K081279

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GXY 2009-01-21

UNIVERSAL ELECTRODES

Applicant Neurometrix, Inc.

K number K083818

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GXY 2008-11-28

GE ENTROPY SENSOR

Applicant GE Healthcare

K number K082540

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GXY 2008-09-29

UNIVERSAL ELECTRODES

Applicant Neurometrix, Inc.

K number K081871

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GXY 2008-08-05

DERMABIOSAFE

Applicant Complete Product Resources

K number K080298

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GXY 2008-08-04

SELF-ADHESIVE ELECTRODES

Applicant Cathay Health Care Equipment Manufacturing, Inc.

K number K080276

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GXY 2008-07-02

ELECTRODE ARRAY CAP

Applicant Electrode Arrays

K number K071446

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GXY 2008-06-13

FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058

Applicant Lorenz Biotech S.P.A.

K number K080902

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GXY 2008-05-30

COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE

Applicant Columbia Scientific Development, LLC

K number K080386

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GXY 2008-05-01

DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES

Applicant Technomed Europe

K number K073532

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GXY 2008-04-24

TARGET STERILE ELECTRODE

Applicant Vision Quest Industries, Inc.

K number K072799

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GXY 2007-12-21

GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)

Applicant GE Healthcare

K number K062580

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GXY 2007-10-19

CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE

Applicant Technomed Europe

K number K072016

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GXY 2007-09-07

GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE

Applicant Ives Eeg Solutions, Inc.

K number K071118

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GXY 2007-05-23

CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODES

Applicant Pepin Mfg., Inc.

K number K070807

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GXY 2007-05-07

TOP-RANK ADHESIVE ELECTRODE

Applicant Top-Rank Health Care Equipment Co., Ltd.

K number K070612

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GXY 2007-02-05

ZIPPREP ELECTRODE

Applicant Aspect Medical Systems, Inc.

K number K070069

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GXY 2007-01-04

GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES

Applicant Gemore Technology Co, Ltd.

K number K062675

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GXY 2006-12-19

SUNSPOTS PRE-GELLED SURFACE ELECTRODES

Applicant Axon Systems, Inc.

K number K062198

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GXY 2006-12-13

BIS BILATERAL SENSOR

Applicant Aspect Medical Systems, Inc.

K number K062692

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GXY 2006-12-11

WICK ELECTRODE, MODEL M019260

Applicant Intelligent Hearing Systems

K number K063402

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GXY 2006-08-14

XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES

Applicant Excel Tech. , Ltd.

K number K061269

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GXY 2006-05-31

INSPIRSTAR GLOVE ELECTRODE

Applicant Inspirstar, Inc.

K number K061343

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GXY 2006-05-10

RHYTHMLINK DISC ELECTRODES

Applicant Rhythmlink International, LLC

K number K061148

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GXY 2006-03-29

INTERX500 FLEXIBLE ARRAY ELECTRODE

Applicant Neuro Resource Group, Inc.

K number K053626

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GXY 2005-12-27

PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES

Applicant Summit Manufacturing, LLC

K number K052875

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GXY 2005-12-20

THERAKNIT GARMENT ELECTRODE

Applicant Neurotron Medical

K number K053214

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GXY 2005-08-23

CUTANEOUS ELECTRODE

Applicant Rhythmlink International, LLC

K number K052188

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GXY 2005-08-04

AMBU NEUROLINE GROUND

Applicant Ambu, Inc.

K number K051529

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GXY 2005-05-13

EVERLIFE

Applicant Everlife Medical Instrument Co., Ltd.

K number K050788

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GXY 2005-05-13

EZ-STIK ELECTRODES

Applicant Naimco, Inc.

K number K050469

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GXY 2005-01-12

BRAINET KIT

Applicant Jordan Neuroscience, Inc.

K number K043009

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GXY 2004-09-22

MANTRA ELECTRODE

Applicant Mantra Intl. (Hk) , Ltd.

K number K041902

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GXY 2004-09-03

PROTENS ELECTRODE

Applicant Bio Protech, Inc.

K number K042301

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GXY 2004-08-09

VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART

Applicant Conmedcorp

K number K041953

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GXY 2004-07-06

BIS PEDIATRIC SENSOR

Applicant Aspect Medical Systems, Inc.

K number K041670

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GXY 2004-03-05

AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE

Applicant Ambu, Inc.

K number K032278

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GXY 2003-09-23

MYOSYSTEM WITH CUSTOMIZING

Applicant Otto Bock Healthcare LP

K number K032833

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GXY 2003-09-12

THERMOSKIN CONDUCTIVE PADS

Applicant United Pacific, Inc.

K number K030564

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GXY 2003-06-11

ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES

Applicant Eletromed, Inc.

K number K030800

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GXY 2003-05-05

SOFT-TOUCH TENS ELECTRODE

Applicant Pain Management Technologies

K number K030375

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GXY 2003-04-28

FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130

Applicant Enraf-Nonius, B.V.

K number K030297

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GXY 2003-03-04

HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES

Applicant Home Care Technology Co., Ltd.

K number K022917

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GXY 2003-03-03

MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005

Applicant Vermont Medical, Inc.

K number K021537

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GXY 2002-12-13

AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS

Applicant Ag Garments

K number K023212

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GXY 2002-10-08

MODEL 4310 PSARRAY2 EEG ELECTRODE

Applicant Physiometrix, Inc.

K number K020670

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GXY 2002-09-26

DOCXS B SERIES ELECTRODES

Applicant Docxs, LLC

K number K020903

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GXY 2002-08-23

BRAINET

Applicant Nicolet Biomedical, Inc.

K number K021986

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GXY 2002-08-13

SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY

Applicant The Electrode Store, Inc.

K number K022197

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GXY 2002-07-12

SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES

Applicant Cathay International, Ltd.

K number K020735

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GXY 2002-05-10

THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG

Applicant The Electrode Store, Inc.

K number K020445

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GXY 2002-04-24

LYMPHA VISION-EXPERT

Applicant Bexley Trading, Inc.

K number K003896

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GXY 2002-04-16

CHIN ELECTRODE

Applicant Dymedix, Inc.

K number K020468

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GXY 2002-02-05

LIFECARE 55 CM SQUARE, LIFECARE 44 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL

Applicant Everyway Medical Instruments Co.,Ltd

K number K012463

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GXY 2001-12-27

KIMSTIM AURICULAR ELECTRODE

Applicant Kim Institute For Rehabilitation Medicine, P.C.

K number K011691

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GXY 2001-12-14

MODIFICATION TO:APEX MEDICAL IF-4100

Applicant Apex Medical Corp.

K number K013813

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GXY 2001-10-05

COM-PATCH

Applicant Apex Medical Corp.

K number K012140

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GXY 2001-09-06

LEAD-LOK REUSABLE TENS/ NMES ELECTRODES

Applicant Lead-Lok, Inc.

K number K010431

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GXY 2001-06-13

SELF-ADHESIVE ELECTRODES

Applicant Pain Management Technologies

K number K011411

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GXY 2001-05-23

KM-30 TENS ELECTRODE

Applicant Katecho, Inc.

K number K010543

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GXY 2001-05-03

NEUROPLUS, MODEL A10040, A10041, A10042, A10043

Applicant Vermont Medical, Inc.

K number K010638

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GXY 2001-02-02

WANDY SILICONE CONDUCTIVE RUBBER PAD

Applicant Wandy Rubber Industrial Co., Ltd.

K number K002227

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GXY 2001-02-02

WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE

Applicant Wandy Rubber Industrial Co., Ltd.

K number K002219

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GXY 2000-11-27

SOFTSENS

Applicant Integrated Biosensing Technologies

K number K001521

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