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
121–144 of 441
Cleared Nov 26, 2012
SENSUS ELECTRODE
K121816
Neurometrix, Inc.
Neurology · 159d
Cleared Oct 15, 2012
REUSABLE CUTANEOUS ELECTRODE
K121483
Ampcare, LLC
Neurology · 150d
Cleared Aug 20, 2012
DYNATRON THERMOSTIM PROBE-DONE
K120835
Dynatronics Corporation
Neurology · 153d
Cleared Jun 11, 2012
DISPOSABLE ADHESIVE SURFACE ELECTRODE
K120494
Spes Medica Srl
Neurology · 115d
Cleared May 17, 2012
LONG LIFE PADTM
K120516
Omron Healthcare, Inc.
Neurology · 86d
Cleared Jan 27, 2012
ELECTRO-CAP SYSTEM
K112319
Electro-Cap Intl., Inc.
Neurology · 169d
Cleared Jan 25, 2012
THERATRODE
K112312
Phoenix Medical Devices, Llp
Neurology · 167d
Cleared Jan 20, 2012
NEUROTECH RECOVERY
K112934
Bio-Medical Research, Ltd.
Neurology · 109d
Cleared Oct 14, 2011
DISPOSABLE ELECTRODE
K111737
Sanibel Supply
Neurology · 115d
Cleared Sep 13, 2011
REUSABLE STIMULATING ELECTRODES
K111270
Bio Protech, Inc.
Neurology · 133d
Cleared Aug 30, 2011
FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE
K110289
Xian Friendship Medical Electronics Co., Ltd.
Neurology · 210d
Cleared Aug 24, 2011
LIFECARE CONDUCTIVE GARMENTS
K103719
Everyway Medical Instruments Co.,Ltd
Neurology · 246d
Cleared Jun 29, 2011
WAVEGUARD (TM) EEG CAP
K110223
Eemagine Medical Imaging Solutions GmbH
Neurology · 155d
Cleared Jun 03, 2011
AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40
K102614
Bio-Medical Research, Ltd.
Neurology · 266d
Cleared Dec 02, 2010
ADHESIVE ELECTRODES
K102842
Reno Medical Limited
Neurology · 64d
Cleared Sep 03, 2010
SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE
K100418
Covidien
Neurology · 199d
Cleared Jan 29, 2010
STATNET, MODEL 3100
K092828
Hydrodot, Inc.
Neurology · 137d
Cleared Dec 22, 2009
DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE
K091762
Covidien
Neurology · 189d
Cleared Dec 18, 2009
GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM
K092546
Gmdasz Manufacturing Co., Ltd.
Neurology · 121d
Cleared Dec 07, 2009
MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411
K092793
Bio-Medical Research, Ltd.
Neurology · 87d
Cleared Dec 04, 2009
EMSI GARMENT ELECTRODES
K090889
Emsi
Neurology · 248d
Cleared Oct 23, 2009
BIS QUATRO SENSOR
K093183
Aspect Medical Systems, Inc.
Neurology · 14d
Cleared Aug 14, 2009
SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS
K083758
The Electrode Store, Inc.
Neurology · 240d
Cleared Aug 03, 2009
LIFECARE ELECTRODES
K083302
Everyway Medical Instruments Co.,Ltd
Neurology · 266d