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
97–120 of 441
Cleared Feb 18, 2016
Ennova Self-adhesive Electrode
K152648
Suzhou Ennova Electronics Technology Co.,Ltd
Neurology · 155d
Cleared Oct 09, 2015
Dr-Ho's Foot Pad Electrode
K151693
Drtv Asia, Ltd.
Neurology · 108d
Cleared Sep 29, 2015
Neon EEG
K151576
Incereb, Ltd.
Neurology · 110d
Cleared Aug 25, 2015
Zekang Self-adhesive Electrode
K150971
Jiangsu Zekang Medical Technology Co., Ltd.
Neurology · 134d
Cleared Jul 28, 2015
Philips Self-Adhesive Electrodes
K151033
Philips Consumer Lifestyle
Neurology · 102d
Cleared Jun 03, 2015
DISPOSABLE PRE-GELLED SURFACE ELECTRODE
K142159
Rochester Electro Medical, Inc.
Neurology · 301d
Cleared Apr 16, 2015
BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES)
K143506
Covidien
Neurology · 127d
Cleared Nov 17, 2014
ASCEND ELECTRODE
K140586
Neurometrix, Inc.
Neurology · 255d
Cleared Nov 17, 2014
CUTANEOUS ELECTRODES
K142099
Bio Protech, Inc.
Neurology · 108d
Cleared Nov 14, 2014
GARMENT ELECTRODES
K141076
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 203d
Cleared Nov 14, 2014
WEARABLE THERAPY GARMENTS
K141342
Axiobionics, LLC
Neurology · 177d
Cleared Jul 25, 2014
HIVOX SELF ADHESIVE ELECTRODE GEL PADS
K131720
Hivox Biotek, Inc.
Neurology · 408d
Cleared Jun 03, 2014
AXON-BUS PROSTHETIC SYSTEM
K123795
Otto Bock Austria
Neurology · 540d
Cleared May 21, 2014
SKINTACT
K140340
Leonhard Lang GmbH
Neurology · 99d
Cleared Feb 13, 2014
PALS PLATINUM NEUROSTIMULATION ELECTRODES
K132422
Axelgaard Mfg. Co., Ltd.
Neurology · 192d
Cleared Jan 24, 2014
DYNATRON PELTIER THERMOSTIM PROBE
K132057
Dynatronics Corp.
Neurology · 205d
Cleared Dec 20, 2013
WANDY SELF-ADHESIVE ELECTRODES
K132998
Wandy Rubber Industrial Co., Ltd.
Neurology · 87d
Cleared Nov 22, 2013
ADHESIVE ELECTRODES
K132588
Top-Rank Health Care Equipment Co., Ltd.
Neurology · 95d
Cleared Jul 17, 2013
VALUTRODE NEUROSTIMLATION ELECTRODES
K130987
Axelgaard Mfg. Co., Ltd.
Neurology · 99d
Cleared Jun 21, 2013
INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)
K130816
Neuro Resource Group, Inc.
Neurology · 88d
Cleared May 30, 2013
MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE
K130287
Rhythmlink International, LLC
Neurology · 114d
Cleared Apr 24, 2013
DE48-PLUS
K123915
Grass Technologies, an Astro-Med, Inc. Product Gro
Neurology · 126d
Cleared Jan 25, 2013
ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE
K113375
Eswallow USA
Neurology · 436d
Cleared Dec 19, 2012
PMT TRUSCAN SURFACE ELECTRODE
K122376
Pmt Corp.
Neurology · 135d