FDA Product Code
FDA Product Code GXY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1320
510(k) Clearances — 440 records · page 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K142159 | DISPOSABLE PRE-GELLED SURFACE ELECTRODE | Rochester Electro Medical, Inc. | 2015-06-03 | Traditional | PDF ↗ |
| K143506 | 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) | Covidien | 2015-04-16 | Traditional | PDF ↗ |
| K140586 | ASCEND ELECTRODE | Neurometrix, Inc. | 2014-11-17 | Traditional | PDF ↗ |
| K142099 | CUTANEOUS ELECTRODES | Bio Protech, Inc. | 2014-11-17 | Traditional | PDF ↗ |
| K141076 | GARMENT ELECTRODES | Shenzhen Dongdixin Technology Co., Ltd. | 2014-11-14 | Traditional | PDF ↗ |
| K141342 | WEARABLE THERAPY GARMENTS | Axiobionics, LLC | 2014-11-14 | Traditional | PDF ↗ |
| K131720 | HIVOX SELF ADHESIVE ELECTRODE GEL PADS | Hivox Biotek, Inc. | 2014-07-25 | Traditional | PDF ↗ |
| K123795 | AXON-BUS PROSTHETIC SYSTEM | Otto Bock Austria | 2014-06-03 | Traditional | PDF ↗ |
| K140340 | SKINTACT | Leonhard Lang GmbH | 2014-05-21 | Traditional | PDF ↗ |
| K132422 | PALS PLATINUM NEUROSTIMULATION ELECTRODES | Axelgaard Mfg. Co., Ltd. | 2014-02-13 | Traditional | PDF ↗ |
| K132057 | DYNATRON PELTIER THERMOSTIM PROBE | Dynatronics Corp. | 2014-01-24 | Traditional | PDF ↗ |
| K132998 | WANDY SELF-ADHESIVE ELECTRODES | Wandy Rubber Industrial Co., Ltd. | 2013-12-20 | Traditional | PDF ↗ |
| K132588 | ADHESIVE ELECTRODES | Top-Rank Health Care Equipment Co., Ltd. | 2013-11-22 | Traditional | PDF ↗ |
| K130987 | VALUTRODE NEUROSTIMLATION ELECTRODES | Axelgaard Mfg. Co., Ltd. | 2013-07-17 | Traditional | PDF ↗ |
| K130816 | INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE) | Neuro Resource Group, Inc. | 2013-06-21 | Traditional | PDF ↗ |
| K130287 | MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE | Rhythmlink International, LLC | 2013-05-30 | Traditional | PDF ↗ |
| K123915 | DE48-PLUS | Grass Technologies, an Astro-Med, Inc. Product Gro | 2013-04-24 | Traditional | PDF ↗ |
| K113375 | ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE | Eswallow USA | 2013-01-25 | Traditional | PDF ↗ |
| K122376 | PMT TRUSCAN SURFACE ELECTRODE | Pmt Corp. | 2012-12-19 | Traditional | PDF ↗ |
| K121816 | SENSUS ELECTRODE | Neurometrix, Inc. | 2012-11-26 | Traditional | PDF ↗ |
| K121483 | REUSABLE CUTANEOUS ELECTRODE | Ampcare, LLC | 2012-10-15 | Traditional | PDF ↗ |
| K120835 | DYNATRON THERMOSTIM PROBE-DONE | Dynatronics Corporation | 2012-08-20 | Traditional | PDF ↗ |
| K120494 | DISPOSABLE ADHESIVE SURFACE ELECTRODE | Spes Medica Srl | 2012-06-11 | Traditional | PDF ↗ |
| K120516 | LONG LIFE PADTM | Omron Healthcare, Inc. | 2012-05-17 | Traditional | PDF ↗ |
| K112319 | ELECTRO-CAP SYSTEM | Electro-Cap Intl., Inc. | 2012-01-27 | Traditional | PDF ↗ |
| K112312 | THERATRODE | Phoenix Medical Devices, Llp | 2012-01-25 | Traditional | PDF ↗ |
| K112934 | NEUROTECH RECOVERY | Bio-Medical Research, Ltd. | 2012-01-20 | Traditional | PDF ↗ |
| K111737 | DISPOSABLE ELECTRODE | Sanibel Supply | 2011-10-14 | Special | PDF ↗ |
| K111270 | REUSABLE STIMULATING ELECTRODES | Bio Protech, Inc. | 2011-09-13 | Traditional | PDF ↗ |
| K110289 | FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE | Xian Friendship Medical Electronics Co., Ltd. | 2011-08-30 | Traditional | PDF ↗ |
| K103719 | LIFECARE CONDUCTIVE GARMENTS | Everyway Medical Instruments Co.,Ltd | 2011-08-24 | Abbreviated | PDF ↗ |
| K110223 | WAVEGUARD (TM) EEG CAP | Eemagine Medical Imaging Solutions GmbH | 2011-06-29 | Traditional | PDF ↗ |
| K102614 | AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 | Bio-Medical Research, Ltd. | 2011-06-03 | Traditional | PDF ↗ |
| K102842 | ADHESIVE ELECTRODES | Reno Medical Limited | 2010-12-02 | Traditional | PDF ↗ |
| K100418 | SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE | Covidien | 2010-09-03 | Traditional | PDF ↗ |
| K092828 | STATNET, MODEL 3100 | Hydrodot, Inc. | 2010-01-29 | Traditional | PDF ↗ |
| K091762 | DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE | Covidien | 2009-12-22 | Traditional | PDF ↗ |
| K092546 | GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM | Gmdasz Manufacturing Co., Ltd. | 2009-12-18 | Traditional | PDF ↗ |
| K092793 | MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411 | Bio-Medical Research, Ltd. | 2009-12-07 | Traditional | PDF ↗ |
| K090889 | EMSI GARMENT ELECTRODES | Emsi | 2009-12-04 | Traditional | PDF ↗ |
| K093183 | BIS QUATRO SENSOR | Aspect Medical Systems, Inc. | 2009-10-23 | Traditional | PDF ↗ |
| K083758 | SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS | The Electrode Store, Inc. | 2009-08-14 | Traditional | PDF ↗ |
| K083302 | LIFECARE ELECTRODES | Everyway Medical Instruments Co.,Ltd | 2009-08-03 | Traditional | PDF ↗ |
| K091163 | PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST | Fiab Spa | 2009-07-22 | Traditional | PDF ↗ |
| K091854 | BIS CLICK SENSOR/CABLE | Aspect Medical Systems, Inc. | 2009-07-02 | Traditional | PDF ↗ |
| K083756 | GUARDIAN 150 ELECTRODE | Selectivemed Components, Inc. | 2009-06-26 | Traditional | PDF ↗ |
| K090198 | JIAJIAN SELF-ADHESIVE ELECTRODE | Wuxi Jiajian Medical Instrument Co., Ltd. | 2009-06-23 | Traditional | PDF ↗ |
| K090951 | RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBG | Rs Medical | 2009-06-05 | Traditional | PDF ↗ |
| K083441 | FREEDOM STIM 100 AND 200 ELECTRODE AND LEADWIRE EXTENSION | Motion Medical Products, LLC | 2009-05-22 | Traditional | PDF ↗ |
| K083350 | TENS/NMES/FES STIMULATING ELECTRODE | Covidien LP | 2009-04-21 | Traditional | PDF ↗ |
| K082065 | WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP | Well-Life Healthcare Limited | 2009-04-10 | Traditional | PDF ↗ |
| K081279 | PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000 | Transfer Technology | 2009-01-23 | Traditional | PDF ↗ |
| K083818 | UNIVERSAL ELECTRODES | Neurometrix, Inc. | 2009-01-21 | Special | PDF ↗ |
| K082540 | GE ENTROPY SENSOR | GE Healthcare | 2008-11-28 | Traditional | PDF ↗ |
| K081871 | UNIVERSAL ELECTRODES | Neurometrix, Inc. | 2008-09-29 | Traditional | PDF ↗ |
| K080298 | DERMABIOSAFE | Complete Product Resources | 2008-08-05 | Traditional | PDF ↗ |
| K080276 | SELF-ADHESIVE ELECTRODES | Cathay Health Care Equipment Manufacturing, Inc. | 2008-08-04 | Traditional | PDF ↗ |
| K071446 | ELECTRODE ARRAY CAP | Electrode Arrays | 2008-07-02 | Abbreviated | PDF ↗ |
| K080902 | FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058 | Lorenz Biotech S.P.A. | 2008-06-13 | Abbreviated | PDF ↗ |
| K080386 | COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE | Columbia Scientific Development, LLC | 2008-05-30 | Traditional | PDF ↗ |
| K073532 | DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES | Technomed Europe | 2008-05-01 | Traditional | PDF ↗ |
| K072799 | TARGET STERILE ELECTRODE | Vision Quest Industries, Inc. | 2008-04-24 | Traditional | PDF ↗ |
| K062580 | GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784) | GE Healthcare | 2007-12-21 | Traditional | PDF ↗ |
| K072016 | CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE | Technomed Europe | 2007-10-19 | Traditional | PDF ↗ |
| K071118 | GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE | Ives Eeg Solutions, Inc. | 2007-09-07 | Traditional | PDF ↗ |
| K070807 | CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODES | Pepin Mfg., Inc. | 2007-05-23 | Abbreviated | PDF ↗ |
| K070612 | TOP-RANK ADHESIVE ELECTRODE | Top-Rank Health Care Equipment Co., Ltd. | 2007-05-07 | Traditional | PDF ↗ |
| K070069 | ZIPPREP ELECTRODE | Aspect Medical Systems, Inc. | 2007-02-05 | Special | PDF ↗ |
| K062675 | GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES | Gemore Technology Co, Ltd. | 2007-01-04 | Traditional | PDF ↗ |
| K062198 | SUNSPOTS PRE-GELLED SURFACE ELECTRODES | Axon Systems, Inc. | 2006-12-19 | Traditional | PDF ↗ |
| K062692 | BIS BILATERAL SENSOR | Aspect Medical Systems, Inc. | 2006-12-13 | Special | PDF ↗ |
| K063402 | WICK ELECTRODE, MODEL M019260 | Intelligent Hearing Systems | 2006-12-11 | Traditional | PDF ↗ |
| K061269 | XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES | Excel Tech. , Ltd. | 2006-08-14 | Traditional | PDF ↗ |
| K061343 | INSPIRSTAR GLOVE ELECTRODE | Inspirstar, Inc. | 2006-05-31 | Traditional | PDF ↗ |
| K061148 | RHYTHMLINK DISC ELECTRODES | Rhythmlink International, LLC | 2006-05-10 | Traditional | PDF ↗ |
| K053626 | INTERX500 FLEXIBLE ARRAY ELECTRODE | Neuro Resource Group, Inc. | 2006-03-29 | Traditional | PDF ↗ |
| K052875 | PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES | Summit Manufacturing, LLC | 2005-12-27 | Traditional | PDF ↗ |
| K053214 | THERAKNIT GARMENT ELECTRODE | Neurotron Medical | 2005-12-20 | Traditional | PDF ↗ |
| K052188 | CUTANEOUS ELECTRODE | Rhythmlink International, LLC | 2005-08-23 | Traditional | PDF ↗ |
| K051529 | AMBU NEUROLINE GROUND | Ambu, Inc. | 2005-08-04 | Traditional | PDF ↗ |
| K050469 | EZ-STIK ELECTRODES | Naimco, Inc. | 2005-05-13 | Traditional | PDF ↗ |
| K050788 | EVERLIFE | Everlife Medical Instrument Co., Ltd. | 2005-05-13 | Traditional | PDF ↗ |
| K043009 | BRAINET KIT | Jordan Neuroscience, Inc. | 2005-01-12 | Traditional | PDF ↗ |
| K041902 | MANTRA ELECTRODE | Mantra Intl. (Hk) , Ltd. | 2004-09-22 | Traditional | PDF ↗ |
| K042301 | PROTENS ELECTRODE | Bio Protech, Inc. | 2004-09-03 | Traditional | PDF ↗ |
| K041953 | VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART | Conmedcorp | 2004-08-09 | Special | PDF ↗ |
| K041670 | BIS PEDIATRIC SENSOR | Aspect Medical Systems, Inc. | 2004-07-06 | Special | PDF ↗ |
| K032278 | AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE | Ambu, Inc. | 2004-03-05 | Traditional | PDF ↗ |
| K032833 | MYOSYSTEM WITH CUSTOMIZING | Otto Bock Healthcare LP | 2003-09-23 | Traditional | PDF ↗ |
| K030564 | THERMOSKIN CONDUCTIVE PADS | United Pacific, Inc. | 2003-09-12 | Traditional | PDF ↗ |
| K030800 | ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES | Eletromed, Inc. | 2003-06-11 | Traditional | PDF ↗ |
| K030375 | SOFT-TOUCH TENS ELECTRODE | Pain Management Technologies | 2003-05-05 | Traditional | PDF ↗ |
| K030297 | FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 | Enraf-Nonius, B.V. | 2003-04-28 | Traditional | PDF ↗ |
| K022917 | HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES | Home Care Technology Co., Ltd. | 2003-03-04 | Traditional | PDF ↗ |
| K021537 | MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005 | Vermont Medical, Inc. | 2003-03-03 | Traditional | PDF ↗ |
| K023212 | AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS | Ag Garments | 2002-12-13 | Traditional | PDF ↗ |
| K020670 | MODEL 4310 PSARRAY2 EEG ELECTRODE | Physiometrix, Inc. | 2002-10-08 | Special | PDF ↗ |
| K020903 | DOCXS B SERIES ELECTRODES | Docxs, LLC | 2002-09-26 | Traditional | PDF ↗ |
| K021986 | BRAINET | Nicolet Biomedical, Inc. | 2002-08-23 | Traditional | PDF ↗ |
| K022197 | SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY | The Electrode Store, Inc. | 2002-08-13 | Traditional | PDF ↗ |
Product code GXY · Class II · Neurology. Data: openFDA.