GXY · Class II · 21 CFR 882.1320

FDA Product Code GXY: Electrode, Cutaneous

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

441
Total
441
Cleared
127d
Avg days
1976
Since
441 devices
169–192 of 441
Cleared Feb 05, 2007
ZIPPREP ELECTRODE
K070069
Aspect Medical Systems, Inc.
Neurology · 28d
Cleared Jan 04, 2007
GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES
K062675
Gemore Technology Co, Ltd.
Neurology · 118d
Cleared Dec 19, 2006
SUNSPOTS PRE-GELLED SURFACE ELECTRODES
K062198
Axon Systems, Inc.
Neurology · 140d
Cleared Dec 13, 2006
BIS BILATERAL SENSOR
K062692
Aspect Medical Systems, Inc.
Neurology · 93d
Cleared Dec 11, 2006
WICK ELECTRODE, MODEL M019260
K063402
Intelligent Hearing Systems
Neurology · 32d
Cleared Aug 14, 2006
XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES
K061269
Excel Tech. , Ltd.
Neurology · 101d
Cleared May 31, 2006
INSPIRSTAR GLOVE ELECTRODE
K061343
Inspirstar, Inc.
Neurology · 16d
Cleared May 10, 2006
RHYTHMLINK DISC ELECTRODES
K061148
Rhythmlink International, LLC
Neurology · 15d
Cleared Mar 29, 2006
INTERX500 FLEXIBLE ARRAY ELECTRODE
K053626
Neuro Resource Group, Inc.
Neurology · 91d
Cleared Dec 27, 2005
PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES
K052875
Summit Manufacturing, LLC
Neurology · 76d
Cleared Dec 20, 2005
THERAKNIT GARMENT ELECTRODE
K053214
Neurotron Medical
Neurology · 33d
Cleared Aug 23, 2005
CUTANEOUS ELECTRODE
K052188
Rhythmlink International, LLC
Neurology · 12d
Cleared Aug 04, 2005
AMBU NEUROLINE GROUND
K051529
Ambu, Inc.
Neurology · 56d
Cleared May 13, 2005
EZ-STIK ELECTRODES
K050469
Naimco, Inc.
Neurology · 79d
Cleared May 13, 2005
EVERLIFE
K050788
Everlife Medical Instrument Co., Ltd.
Neurology · 46d
Cleared Jan 12, 2005
BRAINET KIT
K043009
Jordan Neuroscience, Inc.
Neurology · 72d
Cleared Sep 22, 2004
MANTRA ELECTRODE
K041902
Mantra Intl. (Hk) , Ltd.
Neurology · 70d
Cleared Sep 03, 2004
PROTENS ELECTRODE
K042301
Bio Protech, Inc.
Neurology · 9d
Cleared Aug 09, 2004
VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART
K041953
Conmedcorp
Neurology · 20d
Cleared Jul 06, 2004
BIS PEDIATRIC SENSOR
K041670
Aspect Medical Systems, Inc.
Neurology · 15d
Cleared Mar 05, 2004
AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE
K032278
Ambu, Inc.
Neurology · 225d
Cleared Sep 23, 2003
MYOSYSTEM WITH CUSTOMIZING
K032833
Otto Bock Healthcare LP
Neurology · 12d
Cleared Sep 12, 2003
THERMOSKIN CONDUCTIVE PADS
K030564
United Pacific, Inc.
Neurology · 203d
Cleared Jun 11, 2003
ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES
K030800
Eletromed, Inc.
Neurology · 90d