GXY · Class II · 21 CFR 882.1320

FDA Product Code GXY: Electrode, Cutaneous

Leading manufacturers include Empi, Medtronic Vascular and Labeltape Meditect, Inc..

441
Total
441
Cleared
127d
Avg days
1976
Since
441 devices
217–240 of 441
Cleared Nov 07, 2000
KM-10 TENS ELECTRODE
K000870
Katecho, Inc.
Neurology · 232d
Cleared Sep 27, 2000
ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110
K001980
Aspect Medical Systems, Inc.
Neurology · 90d
Cleared Sep 14, 2000
ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106
K002734
Aspect Medical Systems, Inc.
Neurology · 13d
Cleared Jul 05, 2000
COMFORT STIM
K001117
R & D Medical Products, Inc.
Neurology · 90d
Cleared Jun 16, 2000
ULTRASTIM ELECTRODE, MODEL US4040
K000947
Axelgaard Mfg. Co., Ltd.
Neurology · 85d
Cleared May 11, 2000
MODEL 4300 PSARRAY EEG ELECTRODE SET
K001055
Physiometrix, Inc.
Neurology · 38d
Cleared Apr 18, 2000
QUIK-CAP
K000865
Neuroscan
Neurology · 32d
Cleared Jan 18, 2000
ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076
K994330
Aspect Medical Systems, Inc.
Neurology · 26d
Cleared Dec 17, 1999
ULTRA-GARMENT ELECTRODE
K993130
Newwave Medical, LLC
Neurology · 88d
Cleared Sep 17, 1999
TENS/FES/NMES ELECTRODES
K983097
Uni-Patch, Inc.
Neurology · 389d
Cleared Aug 18, 1999
CUTANEOUS (BAR) ELECTRODE
K991769
Neuro Supplies, Inc.
Neurology · 86d
Cleared Aug 18, 1999
CUTANEOUS (GROUND) ELECTRODE
K991770
Neuro Supplies, Inc.
Neurology · 86d
Cleared Aug 18, 1999
DIGITAL RING ELECTRDE
K991771
Neuro Supplies, Inc.
Neurology · 86d
Cleared Aug 18, 1999
CUTANEOUS (DISC) ELECTRODE
K991772
Neuro Supplies, Inc.
Neurology · 86d
Cleared Jun 22, 1999
BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150
K991199
Biomed Products
Neurology · 75d
Cleared Jun 18, 1999
DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO
K982096
Rapid Mfg. Co.
Neurology · 368d
Cleared Apr 20, 1999
EEG ELECTRODES MODEL 445 SERIES
K982053
Class A Ent.
Neurology · 313d
Cleared Apr 12, 1999
MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES)
K990370
Msb,Uk
Neurology · 63d
Cleared Dec 18, 1998
EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020
K983741
Axelgaard Mfg. Co., Ltd.
Neurology · 57d
Cleared Oct 22, 1998
SLE ELECTRODES AND ACCESSORIES
K980410
Specialized Laboratory Equipment, Ltd.
Neurology · 261d
Cleared Mar 26, 1998
TECA NCS ELECTRODE SYSTEM 2000
K971914
Medelec, Inc. D.B.A. Teca Corp.
Neurology · 307d
Cleared Feb 27, 1998
MSB TENS ELECTRODES (DISPOSABLE)
K980229
Msb , Ltd.
Neurology · 36d
Cleared Aug 29, 1997
DREAM CATCHER
K972122
Rest Technologies, Inc.
Neurology · 85d
Cleared May 15, 1997
NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K
K970639
Medicotest, Inc.
Neurology · 84d