Stimulator, Nerve, Transcutaneous, Over-The-Counter
Regulation 882.5890
10510(k)s in 12 months (231 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NUH
| Company | 510(k)s | Recalls |
|---|---|---|
| Everyway Medical Instruments Co.,Ltd | 14 | 0 |
| Hivox Biotek, Inc. | 11 | 0 |
| Well-Life Healthcare Limited | 11 | 0 |
| Shenzhen Osto Technology Co., Ltd. | 10 | 0 |
| Shenzhen Kentro Medical Electronics Co., Ltd. | 9 | 0 |
| Omron Healthcare, Inc. | 7 | 0 |
| Hong Qiangxing (Shenzhen) Electronics Limited | 6 | 0 |
| Shenzhen Dongdixin Technology Co., Ltd. | 6 | 0 |
| Changsha Yuwen Medical Equipment Co., Ltd. | 4 | 0 |
| Counter Scientific Development (Gz), Ltd. | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 12, 2017 | K162392 | Avazzia Avazzia, Inc. | NUH |
| May 11, 2017 | K170205 | Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 Shenzhen Kentro Medical Electronics Co., Ltd., CN | NUH |
| Apr 29, 2017 | K170145 | Digital TENS Unit Shenzhen Eapply Technology Co., Ltd., CN | NUH |
| Apr 14, 2017 | K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 Jkh Health Co., Ltd., CN | NUH |
| Feb 8, 2017 | K162479 | Smart Pain Reliever, Model LT5019 Shenzhen Dongdixin Technology Co., Ltd., CN | NUH |
| Dec 20, 2016 | K162630 | CP Relief Wand-OTC Mid-America Medical Innovations, LLC | NUH |
| Dec 5, 2016 | K161453 | WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A Well-Life Healthcare Limited, TW | NUH |
| Nov 21, 2016 | K160508 | Electronic Pulse Stimulator Beijing Choice Electronic Technololgy Co., Ltd., CN | NUH |
| Oct 13, 2016 | K161537 | OTC TENS Device, Model PTS-IV Counter Scientific Development (Gz), Ltd., CN | NUH |
| Oct 5, 2016 | K151995 | Painmaster MCT Patch Newmark, Inc. | NUH |
| Sep 15, 2016 | K160255 | HBOTC Muscle and Nerve Stimulator Hb Medical, Inc. | NUH |
| Jul 27, 2016 | K160893 | HANAROCare ReJu M.I.Tech Co., Ltd., KR | NUH |
| Jun 3, 2016 | K160115 | Heat Pain Pro Omron Healthcare, Inc. | NUH |
| May 20, 2016 | K160052 | CUR Model 1 Thimble Bioelectronics, Inc. | NUH |
| May 5, 2016 | K153520 | Electronic Pulse Stimulator Jkh Health Co., Ltd., CN | NUH |
| Feb 12, 2016 | K150277 | Pain Therapy System, Model PTS-II Counter Scientific Development (Gz), Ltd., CN | NUH |
| Jan 13, 2016 | K152374 | LL TENS 160A, LL TENS 160B Fuji Dynamics , Ltd., CN | NUH |
| Jan 5, 2016 | K152954 | Quell Neurometrix, Inc. | NUH |
| Dec 23, 2015 | K152128 | 2-in-1 Abdominal Muscle Training & Back Pain Relief System Tohkai Precision Electrical Manufactory (Shenzhen) Limited, CN | NUH |
| Dec 22, 2015 | K152852 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) Bayer Healthcare, LLC | NUH |
| Dec 16, 2015 | K151279 | Counter OTC TENS Device, Model CSD-737Z Counter Scientific Development (Gz), Ltd., CN | NUH |
| Nov 21, 2015 | K151034 | PainKARE Triowave Technologies | NUH |
| Nov 5, 2015 | K150386 | Tyece OTC TENS Device Tyece , Ltd., HK | NUH |
| Oct 20, 2015 | K150308 | Palm TENS Heat IN A Click, LLC | NUH |
| Oct 16, 2015 | K151479 | EV-820 OTC Pain Relief TENS Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Aug 14, 2015 | K150043 | Transcutaneous Electrical Nerve Stimulators (TENS) Andon Health Co, Ltd., CN | NUH |
| Jul 21, 2015 | K151035 | PulseRelief Philips Consumer Lifestyle | NUH |
| Jul 21, 2015 | K143268 | TENS AND POWERED MUSCLE STIMULATOR Shenzhen As-Tec Technology Co., Ltd., CN | NUH |
| Jul 6, 2015 | K150995 | Electronic Pulse Stimulator Shenzhen Jingkehui Electronic Co.., Ltd., CN | NUH |
| May 29, 2015 | K143430 | SmartTENS Easy Med Instrument Co., Ltd., CN | NUH |
| May 12, 2015 | K150681 | GEMORE OTC TENS Gemore Technology Co, Ltd., TW | NUH |
| Mar 4, 2015 | K133789 | DOLPHIN NEUROSTIM OTC Acumed Medical , Ltd. | NUH |
| Dec 18, 2014 | K142686 | StimPad OTC Aemed, Inc. | NUH |
| Dec 3, 2014 | K141978 | MAXPOWER RELIEF Omron Healthcare, Inc. | NUH |
| Dec 3, 2014 | K133502 | 5000Z FIREFLY SYSTEM Prizm Medical, Inc. | NUH |
| Nov 14, 2014 | K141299 | OTC COMBO TENS/EMS SYSTEM Well-Life Healthcare Limited, TW | NUH |
| Nov 12, 2014 | K133929 | HEALTH EXPERT ELCTRONIC STIMULATOR Shenzhen Osto Technology Company Limited, CN | NUH |
| Sep 17, 2014 | K141260 | ELECTRONIC PULSE STIMULATOR Shenzhen Jingkehui Electronic Co.., Ltd. | NUH |
| Aug 28, 2014 | K140168 | EASYSTIM TN28_OTC Easymed Instruments Co., Ltd., CN | NUH |
| Aug 26, 2014 | K133979 | TENS Sunmas (H.K.) Trading Limited, CN | NUH |
| Aug 6, 2014 | K131290 | IQ TECHNOLOGIES Iq Technologies, Inc. | NUH |
| Jul 3, 2014 | K140333 | ASCEND Neurometrix, Inc. | NUH |
| Jun 27, 2014 | K140650 | HIVOX ELECTRIC STIMULATOR OTC TENS Hivox Biotek, Inc., TW | NUH |
| Apr 24, 2014 | K132993 | COUNTER OTC TENS DEVICE Counter Scientific Development (Gz), Ltd. | NUH |
| Apr 24, 2014 | K132563 | PINOOK STIMULATOR Pinook USA | NUH |
| Apr 24, 2014 | K131956 | QUICK RELAX PRO Healthcare Innovations, LLC | NUH |
| Jan 28, 2014 | K133723 | OTC PATCH Well-Life Healthcare Limited, TW | NUH |
| Jan 24, 2014 | K131910 | MPP Marc Pro | NUH |
| Dec 20, 2013 | K131933 | ELECTRONIC PULSE MASSAGER Gurin Products, LLC | NUH |
| Nov 15, 2013 | K131921 | ELECTRONIC PULSE STIMULATOR Shenzhen Jingkehui Electronic Co.., Ltd. | NUH |
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