GXY · Class II · 21 CFR 882.1320

FDA Product Code GXY: Electrode, Cutaneous

Leading manufacturers include Empi, Medtronic Vascular and Aspect Medical Systems, Inc..

441
Total
441
Cleared
127d
Avg days
1976
Since
441 devices
145–168 of 441
Cleared Jul 22, 2009
PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST
K091163
Fiab Spa
Neurology · 91d
Cleared Jul 02, 2009
BIS CLICK SENSOR/CABLE
K091854
Aspect Medical Systems, Inc.
Neurology · 13d
Cleared Jun 26, 2009
GUARDIAN 150 ELECTRODE
K083756
Selectivemed Components, Inc.
Neurology · 191d
Cleared Jun 23, 2009
JIAJIAN SELF-ADHESIVE ELECTRODE
K090198
Wuxi Jiajian Medical Instrument Co., Ltd.
Neurology · 147d
Cleared Jun 05, 2009
RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBG
K090951
Rs Medical
Neurology · 63d
Cleared May 22, 2009
FREEDOM STIM 100 AND 200 ELECTRODE AND LEADWIRE EXTENSION
K083441
Motion Medical Products, LLC
Neurology · 183d
Cleared Apr 21, 2009
TENS/NMES/FES STIMULATING ELECTRODE
K083350
Covidien LP
Neurology · 159d
Cleared Apr 10, 2009
WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP
K082065
Well-Life Healthcare Limited
Neurology · 262d
Cleared Jan 23, 2009
PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000
K081279
Transfer Technology
Neurology · 262d
Cleared Jan 21, 2009
UNIVERSAL ELECTRODES
K083818
Neurometrix, Inc.
Neurology · 30d
Cleared Nov 28, 2008
GE ENTROPY SENSOR
K082540
Ge Healthcare
Neurology · 87d
Cleared Sep 29, 2008
UNIVERSAL ELECTRODES
K081871
Neurometrix, Inc.
Neurology · 90d
Cleared Aug 05, 2008
DERMABIOSAFE
K080298
Complete Product Resources
Neurology · 182d
Cleared Aug 04, 2008
SELF-ADHESIVE ELECTRODES
K080276
Cathay Health Care Equipment Manufacturing, Inc.
Neurology · 182d
Cleared Jul 02, 2008
ELECTRODE ARRAY CAP
K071446
Electrode Arrays
Neurology · 405d
Cleared Jun 13, 2008
FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057
K080902
Lorenz Biotech S.P.A.
Neurology · 72d
Cleared May 30, 2008
COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE
K080386
Columbia Scientific Development, LLC
Neurology · 107d
Cleared May 01, 2008
DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES
K073532
Technomed Europe
Neurology · 136d
Cleared Apr 24, 2008
TARGET STERILE ELECTRODE
K072799
Vision Quest Industries, Inc.
Neurology · 206d
Cleared Dec 21, 2007
GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)
K062580
Ge Healthcare
Neurology · 477d
Cleared Oct 19, 2007
CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE
K072016
Technomed Europe
Neurology · 88d
Cleared Sep 07, 2007
GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE
K071118
Ives Eeg Solutions, Inc.
Neurology · 140d
Cleared May 23, 2007
CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES
K070807
Pepin Mfg., Inc.
Neurology · 58d
Cleared May 07, 2007
TOP-RANK ADHESIVE ELECTRODE
K070612
Top-Rank Health Care Equipment Co., Ltd.
Neurology · 63d