Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 2000-11-07

KM-10 TENS ELECTRODE

Applicant Katecho, Inc.

K number K000870

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GXY 2000-09-27

ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110

Applicant Aspect Medical Systems, Inc.

K number K001980

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GXY 2000-09-14

ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106

Applicant Aspect Medical Systems, Inc.

K number K002734

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GXY 2000-07-05

COMFORT STIM

Applicant R & D Medical Products, Inc.

K number K001117

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GXY 2000-06-16

ULTRASTIM ELECTRODE, MODEL US4040

Applicant Axelgaard Mfg. Co., Ltd.

K number K000947

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GXY 2000-05-11

MODEL 4300 PSARRAY EEG ELECTRODE SET

Applicant Physiometrix, Inc.

K number K001055

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GXY 2000-04-18

QUIK-CAP

Applicant Neuroscan

K number K000865

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GXY 2000-01-18

ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076

Applicant Aspect Medical Systems, Inc.

K number K994330

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GXY 1999-12-17

ULTRA-GARMENT ELECTRODE

Applicant Newwave Medical, LLC

K number K993130

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GXY 1999-09-17

TENS/FES/NMES ELECTRODES

Applicant Uni-Patch, Inc.

K number K983097

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GXY 1999-08-18

CUTANEOUS (DISC) ELECTRODE

Applicant Neuro Supplies, Inc.

K number K991772

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GXY 1999-08-18

DIGITAL RING ELECTRDE

Applicant Neuro Supplies, Inc.

K number K991771

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GXY 1999-08-18

CUTANEOUS (GROUND) ELECTRODE

Applicant Neuro Supplies, Inc.

K number K991770

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GXY 1999-08-18

CUTANEOUS (BAR) ELECTRODE

Applicant Neuro Supplies, Inc.

K number K991769

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GXY 1999-06-22

BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150

Applicant Biomed Products

K number K991199

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GXY 1999-06-18

DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO

Applicant Rapid Mfg. Co.

K number K982096

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GXY 1999-04-20

EEG ELECTRODES MODEL 445 SERIES

Applicant Class A Ent.

K number K982053

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GXY 1999-04-12

MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES)

Applicant Msb,Uk

K number K990370

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GXY 1998-12-18

EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020

Applicant Axelgaard Mfg. Co., Ltd.

K number K983741

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GXY 1998-10-22

SLE ELECTRODES AND ACCESSORIES

Applicant Specialized Laboratory Equipment, Ltd.

K number K980410

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GXY 1998-03-26

TECA NCS ELECTRODE SYSTEM 2000

Applicant Medelec, Inc. D.B.A. Teca Corp.

K number K971914

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GXY 1998-02-27

MSB TENS ELECTRODES (DISPOSABLE)

Applicant Msb , Ltd.

K number K980229

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GXY 1997-08-29

DREAM CATCHER

Applicant Rest Technologies, Inc.

K number K972122

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GXY 1997-05-15

NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K

Applicant Medicotest, Inc.

K number K970639

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GXY 1997-05-09

VALUETRODE

Applicant Axelgaard Mfg. Co., Ltd.

K number K970426

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GXY 1997-03-06

MEDICOM, TENS ELECTRODES

Applicant Medicotest A/S

K number K965194

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GXY 1997-01-27

AQUABOND ELECTRODE

Applicant Medibond , Ltd.

K number K964433

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GXY 1996-12-16

EEG ELECTRODES

Applicant Teca, Inc.

K number K962283

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GXY 1996-11-15

M & R DISPOSABLE ELECTRODE (14200)

Applicant M & R Mfg., Inc.

K number K963236

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GXY 1996-10-04

ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR

Applicant Aspect Medical Systems, Inc.

K number K961821

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GXY 1996-05-10

MODEL 1220, OR E-NET (54-62 CM)

Applicant Physiometrix, Inc.

K number K961609

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GXY 1996-05-10

EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220

Applicant Uni-Patch, Inc.

K number K961141

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GXY 1996-04-26

MODEL 1240, SMALL E NET

Applicant Physiometrix, Inc.

K number K960885

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GXY 1996-04-26

MODEL 1210, MEDIUM E-NET

Applicant Physiometrix, Inc.

K number K960873

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GXY 1996-04-15

HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500

Applicant Physiometrix, Inc.

K number K960732

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GXY 1996-01-22

EMG DISC RECORDING ELECTRODE

Applicant Chalgren Enterprises, Inc.

K number K953361

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GXY 1996-01-22

EMG RECORDING RING ELECTRODE

Applicant Chalgren Enterprises, Inc.

K number K953356

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GXY 1996-01-22

EMG DISC RECORDING ELECTRODE

Applicant Chalgren Enterprises, Inc.

K number K953354

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GXY 1996-01-03

DISPOSABLE TM-E COCHGTRODE - BLSC PART NO. 101123

Applicant Bio-Logic Systems Corp.

K number K944314

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GXY 1995-12-06

EMG DISC RECORDING ELECTRODE WITH PIN

Applicant Chalgren Enterprises, Inc.

K number K952908

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GXY 1995-12-06

EMG DISC RECORDING ELECTRODE WITH PIN

Applicant Chalgren Enterprises, Inc.

K number K952690

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GXY 1995-11-15

NEUROLOGICAL DIAGNOSTIC DEVICES

Applicant Henley Intl.

K number K943449

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GXY 1995-10-06

32MM NICKEL PLATED DISC ELECTRODE

Applicant Chalgren Enterprises, Inc.

K number K953220

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GXY 1995-10-06

22MM STAINLESS STEEL DISC ELECTRODE, WITH PIN

Applicant Chalgren Enterprises, Inc.

K number K953219

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GXY 1995-09-25

DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-K

Applicant Medicotest, Inc.

K number K952176

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GXY 1995-07-19

BIOFLEX GARMENTS, ASSORTED MODELS

Applicant Bioflex, Inc.

K number K944543

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GXY 1995-06-22

MEDI-TRAC EEG ELECTRODE

Applicant Graphic Controls Corp.

K number K950782

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GXY 1995-04-24

MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE

Applicant Physiometrix, Inc.

K number K946318

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GXY 1995-03-29

RICH-MAR CARBON ELECTRODES

Applicant Rich-Mar Corp.

K number K950491

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GXY 1995-02-21

ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES

Applicant Prizm Medical, Inc.

K number K944487

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GXY 1995-02-21

SMD ELECTRODES

Applicant Scientific Medical Devices, Inc.

K number K943009

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GXY 1995-02-21

CUTANEOUS ELECTRODE

Applicant Maxxim Medical

K number K941986

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GXY 1995-02-03

DISPOSABLE CUTANEOUS ELECTRODES

Applicant Bio-Logic Systems Corp.

K number K941799

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GXY 1995-01-31

NEUROLINK EEG/EP/EMG SURFACE ELECTRODES

Applicant Neuro Supplies, Inc.

K number K942921

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GXY 1994-12-29

EEG CUP ELECTRODE

Applicant Cadwell Laboratories, Inc.

K number K933808

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GXY 1994-12-19

RING ELECTRODE

Applicant Cadwell Laboratories, Inc.

K number K933805

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GXY 1994-12-15

CONMED VERSA STEM NEUROMUSCULAR STIMULATION/TENS

Applicant Conmedcorp

K number K944603

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GXY 1994-12-05

ELECTROFLEX

Applicant Medical Devices, Inc.

K number K943126

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GXY 1994-12-05

SMARTBRACE ELECTRODE

Applicant Medical Devices, Inc.

K number K940012

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GXY 1994-11-04

K-10-VS, DA-05-VS, RECORDING ELECTRODES

Applicant Medicotest, Inc.

K number K941568

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GXY 1994-10-21

ELECTRODE, CUTANEOUS

Applicant Cadwell Laboratories, Inc.

K number K933801

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GXY 1994-10-19

NEUROLOGY ACCESSORIES - MARK-EASY 10-20

Applicant Optimit USA, Inc.

K number K942461

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GXY 1994-09-26

DANTEC 13R45 BAR ELECTRODE

Applicant Dantec Medical, Inc.

K number K934580

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GXY 1994-09-22

CLOTH TENS/BNES ELECTRODE

Applicant Conmed Andover Medical, Inc.

K number K942718

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GXY 1994-09-07

CUTANEOUS ELECTRODE

Applicant Cadwell Laboratories, Inc.

K number K933802

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GXY 1994-07-26

GROUND PLATE ELECTRODE

Applicant Cadwell Laboratories, Inc.

K number K933807

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GXY 1994-07-08

DISPOSABLE TAB ELECTRODE

Applicant Cadwell Laboratories, Inc.

K number K933803

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GXY 1994-07-01

ELECTRO-MESH

Applicant Prizm Medical, Inc.

K number K932299

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GXY 1994-06-30

CONMED VERSA-STIM NEUROMUSCULAR STIMULATION ELECTRODE

Applicant Conmedcorp

K number K936101

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GXY 1994-06-22

CONMED VERSA-STIM INTERFERENTIAL ELECTRODE

Applicant Conmedcorp

K number K940704

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GXY 1993-12-21

CUTANEOUS ELECTRODE

Applicant Medicotest, Inc.

K number K931430

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GXY 1993-12-21

NF-11-E DISPOSABLE REFERENCE/RECORDING ELECTRODE

Applicant Medicotest, Inc.

K number K931426

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GXY 1993-12-08

PHOTOSTRESS RECOVERY TESTER

Applicant Storz Instrument Co.

K number K933814

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GXY 1993-08-16

TPK CUTANEOUS ELECTRODE

Applicant Staodyne, Inc.

K number K931925

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GXY 1993-07-21

EMITENS ELECTRODES

Applicant Electronic Monitors, Inc.

K number K922393

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GXY 1993-07-21

MONOTRODE CUTANEOUS ELECTRODE

Applicant Henley Intl.

K number K915864

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GXY 1993-05-19

DISPOSABLE THERAPY ELECTRODE

Applicant Zimmer Elektromedizin GmbH

K number K924473

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GXY 1993-02-10

REUSABLE FINGER CLIP RECORDING ELECTRODE

Applicant Chalgren Enterprises, Inc.

K number K925706

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GXY 1993-01-28

ELECTROLINK

Applicant Kold Products

K number K920674

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GXY 1992-11-27

PRO-CHILL STIMPACK

Applicant Tko, Inc.

K number K912210

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GXY 1992-06-02

BIO-DETEK TRACERITE EEG ELECTRODE

Applicant Bio-Detek, Inc.

K number K920264

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GXY 1992-02-14

ELECTRODE

Applicant Skylark Device Co., Ltd.

K number K912643

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GXY 1992-01-30

K-STIM

Applicant Katecho, Inc.

K number K913031

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GXY 1992-01-14

ELECTRODE USING PROMEON RG-60 SERIES GEL

Applicant Labeltape Meditect, Inc.

K number K915333

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GXY 1991-11-13

MEDICAL DESIGNS REUSABLE CARBON RUBBER ELECTRODE

Applicant Medical Design & Manufacturing Corp.

K number K914384

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GXY 1991-09-27

PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE

Applicant Medical Design & Manufacturing Corp.

K number K911366

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GXY 1991-08-29

GLOBALCARE ELECTRODE

Applicant Globalcare Intl., Inc.

K number K913373

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GXY 1991-07-30

GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT.

Applicant Somnitec, Inc.

K number K911989

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GXY 1991-07-16

VERSA-STIM ELECTRODE LINE MODIFIED

Applicant Conmedcorp

K number K911069

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GXY 1991-05-28

3M 6830 ELECTRODE

Applicant 3M Healthcare

K number K905539

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GXY 1990-08-30

NORTECH MODEL 87202204 ELECTRODE

Applicant Medtronic Andover Medical, Inc.

K number K903554

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GXY 1990-08-22

GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L

Applicant Medi-Source, Inc.

K number K903402

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GXY 1990-08-17

NORTECH MODEL 86901000 ELECTRODE

Applicant Andover Medical, Inc.

K number K903427

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GXY 1990-07-19

SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT

Applicant Labeltape Meditect, Inc.

K number K902719

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GXY 1990-06-18

LUMISCOPE ELECTRODES MODELS EL-08,11,15,06,21,25

Applicant Lumiscope Co., Inc.

K number K901809

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GXY 1990-06-08

TBD TENS REUSABLE ELECTRODE

Applicant Empi

K number K902195

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GXY 1990-05-02

REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD

Applicant Pioneering Technologies, Inc.

K number K901575

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GXY 1990-04-10

'POLYSTIM'

Applicant Medical Science Products, Inc.

K number K900825

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GXY 1990-03-23

MODIFIED ISLAND SNAP TENS DISPOSABLE ELECTRODE

Applicant Empi

K number K901103

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GXY 1990-03-23

MODIFIED ISLAND PIN TENS DISPOSABLE ELECTRODE

Applicant Empi

K number K901102

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