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GXY

439 FDA 510(k) clearances · Product code

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RecordFirmDate
BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES) (K143506)Covidien2015-04-16
ASCEND ELECTRODE (K140586)Neurometrix, Inc.2014-11-17
CUTANEOUS ELECTRODES (K142099)Bio Protech, Inc.2014-11-17
WEARABLE THERAPY GARMENTS (K141342)Axiobionics, LLC2014-11-14
GARMENT ELECTRODES (K141076)Shenzhen Dongdixin Technology Co., Ltd.2014-11-14
HIVOX SELF ADHESIVE ELECTRODE GEL PADS (K131720)Hivox Biotek, Inc.2014-07-25
AXON-BUS PROSTHETIC SYSTEM (K123795)Otto Bock Austria2014-06-03
SKINTACT (K140340)Leonhard Lang GmbH2014-05-21
PALS PLATINUM NEUROSTIMULATION ELECTRODES (K132422)Axelgaard Mfg. Co., Ltd.2014-02-13
DYNATRON PELTIER THERMOSTIM PROBE (K132057)Dynatronics Corp.2014-01-24
WANDY SELF-ADHESIVE ELECTRODES (K132998)Wandy Rubber Industrial Co., Ltd.2013-12-20
ADHESIVE ELECTRODES (K132588)Top-Rank Health Care Equipment Co., Ltd.2013-11-22
VALUTRODE NEUROSTIMLATION ELECTRODES (K130987)Axelgaard Mfg. Co., Ltd.2013-07-17
INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE) (K130816)Neuro Resource Group, Inc.2013-06-21
MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE (K130287)Rhythmlink International, LLC2013-05-30
DE48-PLUS (K123915)Grass Technologies, an Astro-Med, Inc. Product Gro2013-04-24
ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE (K113375)Eswallow USA2013-01-25
PMT TRUSCAN SURFACE ELECTRODE (K122376)Pmt Corp.2012-12-19
SENSUS ELECTRODE (K121816)Neurometrix, Inc.2012-11-26
REUSABLE CUTANEOUS ELECTRODE (K121483)Ampcare, LLC2012-10-15
DYNATRON THERMOSTIM PROBE-DONE (K120835)Dynatronics Corporation2012-08-20
DISPOSABLE ADHESIVE SURFACE ELECTRODE (K120494)Spes Medica Srl2012-06-11
LONG LIFE PADTM (K120516)Omron Healthcare, Inc.2012-05-17
ELECTRO-CAP SYSTEM (K112319)Electro-Cap Intl., Inc.2012-01-27
THERATRODE (K112312)Phoenix Medical Devices, Llp2012-01-25
NEUROTECH RECOVERY (K112934)Bio-Medical Research, Ltd.2012-01-20
DISPOSABLE ELECTRODE (K111737)Sanibel Supply2011-10-14
REUSABLE STIMULATING ELECTRODES (K111270)Bio Protech, Inc.2011-09-13
FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE (K110289)Xian Friendship Medical Electronics Co., Ltd.2011-08-30
LIFECARE CONDUCTIVE GARMENTS (K103719)Everyway Medical Instruments Co.,Ltd2011-08-24
WAVEGUARD (TM) EEG CAP (K110223)Eemagine Medical Imaging Solutions GmbH2011-06-29
AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 (K102614)Bio-Medical Research, Ltd.2011-06-03
ADHESIVE ELECTRODES (K102842)Reno Medical Limited2010-12-02
SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE (K100418)Covidien2010-09-03
STATNET, MODEL 3100 (K092828)Hydrodot, Inc.2010-01-29
DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE (K091762)Covidien2009-12-22
GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM (K092546)Gmdasz Manufacturing Co., Ltd.2009-12-18
MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411 (K092793)Bio-Medical Research, Ltd.2009-12-07
EMSI GARMENT ELECTRODES (K090889)Emsi2009-12-04
BIS QUATRO SENSOR (K093183)Aspect Medical Systems, Inc.2009-10-23
SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS (K083758)The Electrode Store, Inc.2009-08-14
LIFECARE ELECTRODES (K083302)Everyway Medical Instruments Co.,Ltd2009-08-03
PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST (K091163)Fiab Spa2009-07-22
BIS CLICK SENSOR/CABLE (K091854)Aspect Medical Systems, Inc.2009-07-02
GUARDIAN 150 ELECTRODE (K083756)Selectivemed Components, Inc.2009-06-26
JIAJIAN SELF-ADHESIVE ELECTRODE (K090198)Wuxi Jiajian Medical Instrument Co., Ltd.2009-06-23
RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBG (K090951)Rs Medical2009-06-05
FREEDOM STIM 100 AND 200 ELECTRODE AND LEADWIRE EXTENSION (K083441)Motion Medical Products, LLC2009-05-22
TENS/NMES/FES STIMULATING ELECTRODE (K083350)Covidien LP2009-04-21
WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP (K082065)Well-Life Healthcare Limited2009-04-10
PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000 (K081279)Transfer Technology2009-01-23
UNIVERSAL ELECTRODES (K083818)Neurometrix, Inc.2009-01-21
GE ENTROPY SENSOR (K082540)GE Healthcare2008-11-28
UNIVERSAL ELECTRODES (K081871)Neurometrix, Inc.2008-09-29
DERMABIOSAFE (K080298)Complete Product Resources2008-08-05
SELF-ADHESIVE ELECTRODES (K080276)Cathay Health Care Equipment Manufacturing, Inc.2008-08-04
ELECTRODE ARRAY CAP (K071446)Electrode Arrays2008-07-02
FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058 (K080902)Lorenz Biotech S.P.A.2008-06-13
COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE (K080386)Columbia Scientific Development, LLC2008-05-30
DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES (K073532)Technomed Europe2008-05-01
TARGET STERILE ELECTRODE (K072799)Vision Quest Industries, Inc.2008-04-24
GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784) (K062580)GE Healthcare2007-12-21
CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE (K072016)Technomed Europe2007-10-19
GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE (K071118)Ives Eeg Solutions, Inc.2007-09-07
CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODES (K070807)Pepin Mfg., Inc.2007-05-23
TOP-RANK ADHESIVE ELECTRODE (K070612)Top-Rank Health Care Equipment Co., Ltd.2007-05-07
ZIPPREP ELECTRODE (K070069)Aspect Medical Systems, Inc.2007-02-05
GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES (K062675)Gemore Technology Co, Ltd.2007-01-04
SUNSPOTS PRE-GELLED SURFACE ELECTRODES (K062198)Axon Systems, Inc.2006-12-19
BIS BILATERAL SENSOR (K062692)Aspect Medical Systems, Inc.2006-12-13
WICK ELECTRODE, MODEL M019260 (K063402)Intelligent Hearing Systems2006-12-11
XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES (K061269)Excel Tech. , Ltd.2006-08-14
INSPIRSTAR GLOVE ELECTRODE (K061343)Inspirstar, Inc.2006-05-31
RHYTHMLINK DISC ELECTRODES (K061148)Rhythmlink International, LLC2006-05-10
INTERX500 FLEXIBLE ARRAY ELECTRODE (K053626)Neuro Resource Group, Inc.2006-03-29
PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES (K052875)Summit Manufacturing, LLC2005-12-27
THERAKNIT GARMENT ELECTRODE (K053214)Neurotron Medical2005-12-20
CUTANEOUS ELECTRODE (K052188)Rhythmlink International, LLC2005-08-23
AMBU NEUROLINE GROUND (K051529)Ambu, Inc.2005-08-04
EVERLIFE (K050788)Everlife Medical Instrument Co., Ltd.2005-05-13
EZ-STIK ELECTRODES (K050469)Naimco, Inc.2005-05-13
BRAINET KIT (K043009)Jordan Neuroscience, Inc.2005-01-12
MANTRA ELECTRODE (K041902)Mantra Intl. (Hk) , Ltd.2004-09-22
PROTENS ELECTRODE (K042301)Bio Protech, Inc.2004-09-03
VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART (K041953)Conmedcorp2004-08-09
BIS PEDIATRIC SENSOR (K041670)Aspect Medical Systems, Inc.2004-07-06
AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE (K032278)Ambu, Inc.2004-03-05
MYOSYSTEM WITH CUSTOMIZING (K032833)Otto Bock Healthcare LP2003-09-23
THERMOSKIN CONDUCTIVE PADS (K030564)United Pacific, Inc.2003-09-12
ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES (K030800)Eletromed, Inc.2003-06-11
SOFT-TOUCH TENS ELECTRODE (K030375)Pain Management Technologies2003-05-05
FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 (K030297)Enraf-Nonius, B.V.2003-04-28
HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES (K022917)Home Care Technology Co., Ltd.2003-03-04
MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005 (K021537)Vermont Medical, Inc.2003-03-03
AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS (K023212)Ag Garments2002-12-13
MODEL 4310 PSARRAY2 EEG ELECTRODE (K020670)Physiometrix, Inc.2002-10-08
DOCXS B SERIES ELECTRODES (K020903)Docxs, LLC2002-09-26
BRAINET (K021986)Nicolet Biomedical, Inc.2002-08-23
SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY (K022197)The Electrode Store, Inc.2002-08-13
SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES (K020735)Cathay International, Ltd.2002-07-12
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