GXY · Class II · 21 CFR 882.1320

FDA Product Code GXY: Electrode, Cutaneous

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

440
Total
440
Cleared
127d
Avg days
1976
Since
440 devices
97–120 of 440
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
Cleared Nov 26, 2012
SENSUS ELECTRODE
K121816
Neurometrix, Inc.
Neurology · 159d