Stimulator, Nerve, Transcutaneous, For Pain Relief
Regulation 882.5890
2510(k)s in 12 months (606 all time)
0recalls in 12 months (7 all time)
4recalls that name a 510(k)
Top companies in GZJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomedical Life Systems | 22 | 0 |
| Empi | 17 | 0 |
| Medical Devices, Inc. | 16 | 0 |
| American Imex | 11 | 0 |
| Bio-Medical Research, Ltd. | 10 | 0 |
| Henley Intl. | 10 | 0 |
| Medtronic Vascular | 10 | 0 |
| Skylark Device Co., Ltd. | 10 | 0 |
| Apex Medical Corp. | 8 | 0 |
| Monad Corp. | 8 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 6, 2011 | K112485 | H-WAVE Electronic Waveform Lab, Inc. | GZJ |
| Nov 9, 2011 | K111645 | FD TENS 2050 OR SLIDE TENS MODEL FD2050 Fuji Dynamics , Ltd., CN | GZJ |
| Oct 20, 2011 | K102278 | QUADRA BLOC TENS PLUS Gradient Technologies, LLC | GZJ |
| Aug 3, 2011 | K110350 | KNEEHAB XP Bio-Medical Research, Ltd., IE | GZJ |
| Jul 29, 2011 | K110390 | ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR Handelshaus Dittman GmbH, CN | GZJ |
| Dec 8, 2010 | K100668 | NEMA-ST, MODEL V1.0.2 Nervomatrix, Ltd., IL | GZJ |
| Aug 31, 2010 | K102014 | TENS STIMULATOR, MODELS 2800 AND 3000 Koalaty Products, Inc., CN | GZJ |
| Jun 25, 2010 | K100399 | 4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A Well-Life Healthcare Limited, TW | GZJ |
| May 28, 2010 | K092117 | SCENAR, MODEL 10 Ritm Okb Zao, RU | GZJ |
| Mar 30, 2010 | K092448 | HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2 Hivox Biotek, Inc., TW | GZJ |
| Dec 18, 2009 | K091045 | SMART TENS, MODEL: D-BC05T Body Clock Health Care, Ltd., GB | GZJ |
| Oct 23, 2009 | K092990 | AMD 6605 TENS/NMES Advantageous Medical Devices, LLC | GZJ |
| Oct 21, 2009 | K090866 | NEUROCALM MODEL 1 AND 2 Neuromed Devices, Inc. | GZJ |
| Aug 18, 2009 | K083250 | NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS Aa Neuromed Corp., CA | GZJ |
| Jul 30, 2009 | K091236 | MANTRA COMBO, MODEL MECS 320 Mantra Intl. (Hk) , Ltd. | GZJ |
| Jun 25, 2009 | K091317 | LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK Bio-Medical Research, Ltd., IE | GZJ |
| Jun 5, 2009 | K090922 | EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR Empi | GZJ |
| May 8, 2009 | K090717 | FLEX-TENS Emsi | GZJ |
| May 6, 2009 | K083822 | LASER TOUCHONE Laser Health Technologies, LLC | GZJ |
| Mar 19, 2009 | K081835 | ACTICARE IC AND TSE Bioinduction Limited | GZJ |
| Mar 11, 2009 | K082190 | BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298 Bio-Medical Research, Ltd., IE | GZJ |
| Feb 26, 2009 | K082057 | DX6605E-TENS, DX6605E-G, DX6609-G Shenzhen Dongdixin Technology Co., Ltd., CN | GZJ |
| Feb 20, 2009 | K081255 | SCRAMBLER ST 5 TENS DEVICE Competitive Technologies,Inc. | GZJ |
| Feb 9, 2009 | K082377 | TENSCARE ITOUCH MODEL(S) EASY AND PLUS Tenscare, Ltd., GB | GZJ |
| Feb 5, 2009 | K083030 | TENS-EMS-14 Emsi | GZJ |
| Jan 6, 2009 | K083494 | ULTIMA FIVE Pain Management Technologies | GZJ |
| Dec 15, 2008 | K083202 | COMBOCARE 2000 Xanacare Technologies, LLC | GZJ |
| Nov 28, 2008 | K082011 | MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 Bio-Medical Research, Ltd., IE | GZJ |
| Oct 21, 2008 | K082514 | TENS/EMS COMBO, EMS, TENS Medihightec Medical Co., Ltd., TW | GZJ |
| Sep 9, 2008 | K080221 | EA STIMULATOR Helio Medical Supplies, Inc. | GZJ |
| Aug 29, 2008 | K081141 | COMBOCARE 2000 Xanacare Technologies, LLC | GZJ |
| Jun 20, 2008 | K080304 | PRO TENS, MODEL WL-240 RX Well-Life Healthcare Limited, TW | GZJ |
| Mar 13, 2008 | K071120 | AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999 Aemed, Inc. | GZJ |
| Mar 11, 2008 | K073008 | KFH ENERGY, MODEL: E1 Kingfisher Healthcare NV, GB | GZJ |
| Mar 7, 2008 | K071869 | TENS/IF 14 Emsi | GZJ |
| Feb 7, 2008 | K073438 | PROSTIM 1000/2000 Bio Protech, Inc. | GZJ |
| Feb 1, 2008 | K072123 | HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE Biowave Corporation | GZJ |
| Dec 7, 2007 | K071878 | DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB Med-Lectric Corporation | GZJ |
| Nov 27, 2007 | K071624 | EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR Everlife Medical Equipment Co., Ltd., TW | GZJ |
| Sep 19, 2007 | K062003 | NEURO WAVE 6 Lhasa Oms, Inc. | GZJ |
| Sep 5, 2007 | K071951 | COMFY SERIES: EV-804, EV-805 & EV-806 Everyway Medical Instruments Co.,Ltd | GZJ |
| Aug 24, 2007 | K061828 | LORENZ BIOTECH APTIVA, VERSION 2.13 Lorenz Biotech S.P.A. | GZJ |
| Jul 16, 2007 | K070299 | EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101) Ezfit Technology, Inc., TW | GZJ |
| Jul 6, 2007 | K062616 | WELLNESSPRO 2010 Intelsource Group, Inc. | GZJ |
| Apr 30, 2007 | K062641 | BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1 Avazzia, Inc. | GZJ |
| Apr 25, 2007 | K070474 | NEWLIFE SCIENCES LLC, MODEL TMR Newlife Sciences, LLC | GZJ |
| Mar 21, 2007 | K062547 | QUADRA BLOC TENS, MODEL 101 Gradient Technologies, LLC | GZJ |
| Feb 13, 2007 | K052836 | BODIHEALTH SYSTEM Usa Laser Therapeutics, Inc. | GZJ |
| Feb 6, 2007 | K061516 | STAODYN MAX PRESET, MODEL 4470 Compex Technologies, Inc. | GZJ |
| Jan 22, 2007 | K061650 | SELECT TENS, MODEL 4600S Empi | GZJ |
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