NUH
229 FDA 510(k) clearances · Product code
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| Record | Firm | Date |
|---|---|---|
| Health Expert Electronic Stimulator (model: AST-300L) (K190783) | Shenzhen Osto Technology Company Limited | 2020-03-14 |
| Everyway OTC TENS/EMS Combination (K192589) | Everyway Medical Instruments Co.,Ltd | 2019-12-19 |
| Health Expert Electronic Stimulator (K190673) | Shenzhen Osto Technology Company Limited | 2019-12-12 |
| Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) (K190009) | Hong Qiangxing (Shenzhen) Electronics Limited | 2019-12-02 |
| Healy (K191075) | Timewaver Production GmbH | 2019-11-22 |
| Combo Electrotherapy Device (K192087) | Shenzhen Roundwhale Technology Co. , Ltd. | 2019-11-01 |
| Electronic Pulse Stimulator (K183674) | Shenzhen Leading Perfection Technology Co., Ltd. | 2019-10-11 |
| Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) (K182136) | Shenzhen Osto Technology Co., Ltd. | 2019-10-10 |
| Medi-Direct TENS Pen (K182671) | Jkh USA, LLC | 2019-09-21 |
| Focus TENS Therapy, Model PM710-M/-L (K183215) | Omron Healthcare, Inc. | 2019-09-07 |
| GIM-STIM OTC TENS/EMS System (K190988) | Gemore Technology Co, Ltd. | 2019-08-16 |
| Mini TENS Therapy Device (K182871) | Shenzhen Jumper Medical Equipment Co., Ltd. | 2019-08-01 |
| Transcutaneous Electrical Nerve Stimulator (K183288) | Shenzhen Kentro Medical Electronics Co., Ltd. | 2019-07-30 |
| JKH Stimulator Plus (K191151) | Jkh USA, LLC | 2019-06-21 |
| MHD TENS (K190115) | Minghuangda Electronic Co., Ltd. | 2019-06-19 |
| Portable Electro-Stimulation Therapy Device (K182108) | Guangzhou Longest Science & Technology Co., Ltd. | 2019-04-26 |
| HIVOX OTC Electrical Stimulator (K190347) | Hivox Biotek, Inc. | 2019-03-15 |
| JKH Stimulator Plus (K182203) | Jkh USA, LLC | 2019-03-14 |
| PAT (Pain Alleviation Technologies) (K182267) | Marchan Medical, LLC | 2019-02-27 |
| Maxpower Relief (K182120) | Omron Healthcare, Inc. | 2019-01-10 |
| Neck Care Therapy, Model: SYK 509B (K172897) | Shenzhen Osto Technology Co., Ltd. | 2018-12-07 |
| Low-frequency Multi-function physiotherapy instrument (K172837) | Shenzhen Osto Technology Co., Ltd. | 2018-11-26 |
| PlayMakar Sport Muscle Stimulator, Model PRO-500 (K182581) | Playmakar, Inc. | 2018-11-21 |
| Heat Pain Pro (K181992) | Omron Healthcare, Inc. | 2018-11-09 |
| V2 OTC Pain Relief TENS (K182767) | Everyway Medical Instruments Co.,Ltd | 2018-10-26 |
| A6 OTC Pain Relief TENS (K182753) | Everyway Medical Instruments Co.,Ltd | 2018-10-26 |
| Everyway Wireless TENS & EMS Unit (K181707) | Everyway Medical Instruments Co.,Ltd | 2018-09-26 |
| ThermaCare Quick Therapy TENS (K181102) | Pfizer, Inc. | 2018-09-15 |
| Dual output digital therapy massager (K172834) | Shenzhen Osto Technology Co., Ltd. | 2018-09-06 |
| iStim S2 OTC Pain Relief TENS (K181849) | Everyway Medical Instruments Co., Ldt. | 2018-08-10 |
| BMLS16-1 (K172971) | Biomedical Life Systems, Inc. | 2018-07-08 |
| Wireless Pain Relieve Device (K180331) | Shenzhen Dongdixin Technology Co., Ltd. | 2018-06-22 |
| Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator (K180956) | Shenzhen Roundwhale Technology Co. , Ltd. | 2018-06-07 |
| Balego TENS Digital Edition with Accessories for Pain Relief (OTC) (K181207) | Everyway Medical Instruments Co., Ldt. | 2018-06-06 |
| EV-804 OTC Pain Relief TENS (K172919) | Everyway Medical Instruments Co.,Ltd | 2018-04-19 |
| ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) (K171802) | Bayer Healthcare, LLC | 2018-03-07 |
| Wireless Pain Relieve Device Model: LT5018C (K173462) | Shenzhen Dongdixin Technology Co., Ltd. | 2017-12-08 |
| HIVOX OTC Electrical Stimulator (K171803) | Hivox Biotek, Inc. | 2017-11-29 |
| Dr.MUSIC 3s (K172451) | Smartmedicaldevice Co., Ltd. | 2017-11-17 |
| Mytens Model: BW-TSX (K171026) | Bewell Connect Corp. | 2017-11-01 |
| Avail (K172079) | Omron Healthcare, Inc. | 2017-10-19 |
| OTC Combo TENS/EMS System (K172809) | Well-Life Healthcare Limited | 2017-10-18 |
| WiTouch Pro, WiTouch, Neubac (K171599) | Hollywog, LLC | 2017-09-22 |
| Pain Therapy Device (K163611) | Guangzhou Xinbo Electronic Co., Ltd. | 2017-09-19 |
| EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only (K163166) | Easywell Biomedicals, Inc. | 2017-08-11 |
| Hi-Dow Wireless TENS/EMS System (Model HD-5N) (K163393) | Hi-Dow International, Inc. | 2017-08-04 |
| Livia (K163153) | Lifecare , Ltd. | 2017-06-28 |
| IQ Technologies (K170659) | Iq Technologies, Inc. | 2017-05-26 |
| Avazzia (K162392) | Avazzia, Inc. | 2017-05-12 |
| Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 (K170205) | Shenzhen Kentro Medical Electronics Co., Ltd. | 2017-05-11 |
| Digital TENS Unit (K170145) | Shenzhen Eapply Technology Co., Ltd. | 2017-04-29 |
| Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 (K162517) | Jkh Health Co., Ltd. | 2017-04-14 |
| Smart Pain Reliever, Model LT5019 (K162479) | Shenzhen Dongdixin Technology Co., Ltd. | 2017-02-08 |
| CP Relief Wand-OTC (K162630) | Mid-America Medical Innovations, LLC | 2016-12-20 |
| WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A (K161453) | Well-Life Healthcare Limited | 2016-12-05 |
| Electronic Pulse Stimulator (K160508) | Beijing Choice Electronic Technololgy Co., Ltd. | 2016-11-21 |
| OTC TENS Device, Model PTS-IV (K161537) | Counter Scientific Development (Gz), Ltd. | 2016-10-13 |
| Painmaster MCT Patch (K151995) | Newmark, Inc. | 2016-10-05 |
| HBOTC Muscle and Nerve Stimulator (K160255) | Hb Medical, Inc. | 2016-09-15 |
| HANAROCare ReJu (K160893) | M.I.Tech Co., Ltd. | 2016-07-27 |
| Heat Pain Pro (K160115) | Omron Healthcare, Inc. | 2016-06-03 |
| CUR Model 1 (K160052) | Thimble Bioelectronics, Inc. | 2016-05-20 |
| Electronic Pulse Stimulator (K153520) | Jkh Health Co., Ltd. | 2016-05-05 |
| Pain Therapy System, Model PTS-II (K150277) | Counter Scientific Development (Gz), Ltd. | 2016-02-12 |
| LL TENS 160A, LL TENS 160B (K152374) | Fuji Dynamics , Ltd. | 2016-01-13 |
| Quell (K152954) | Neurometrix, Inc. | 2016-01-05 |
| 2-in-1 Abdominal Muscle Training & Back Pain Relief System (K152128) | Tohkai Precision Electrical Manufactory (Shenzhen) Limited | 2015-12-23 |
| ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) (K152852) | Bayer Healthcare, LLC | 2015-12-22 |
| Counter OTC TENS Device, Model CSD-737Z (K151279) | Counter Scientific Development (Gz), Ltd. | 2015-12-16 |
| PainKARE (K151034) | Triowave Technologies | 2015-11-21 |
| Tyece OTC TENS Device (K150386) | Tyece , Ltd. | 2015-11-05 |
| Palm TENS (K150308) | Heat IN A Click, LLC | 2015-10-20 |
| EV-820 OTC Pain Relief TENS (K151479) | Everyway Medical Instruments Co.,Ltd | 2015-10-16 |
| Transcutaneous Electrical Nerve Stimulators (TENS) (K150043) | Andon Health Co, Ltd. | 2015-08-14 |
| PulseRelief (K151035) | Philips Consumer Lifestyle | 2015-07-21 |
| TENS AND POWERED MUSCLE STIMULATOR (K143268) | Shenzhen As-Tec Technology Co., Ltd. | 2015-07-21 |
| Electronic Pulse Stimulator (K150995) | Shenzhen Jingkehui Electronic Co.., Ltd. | 2015-07-06 |
| SmartTENS (K143430) | Easy Med Instrument Co., Ltd. | 2015-05-29 |
| GEMORE OTC TENS (K150681) | Gemore Technology Co, Ltd. | 2015-05-12 |
| DOLPHIN NEUROSTIM OTC (K133789) | Acumed Medical , Ltd. | 2015-03-04 |
| StimPad OTC (K142686) | Aemed, Inc. | 2014-12-18 |
| MAXPOWER RELIEF (K141978) | Omron Healthcare, Inc. | 2014-12-03 |
| 5000Z FIREFLY SYSTEM (K133502) | Prizm Medical, Inc. | 2014-12-03 |
| OTC COMBO TENS/EMS SYSTEM (K141299) | Well-Life Healthcare Limited | 2014-11-14 |
| HEALTH EXPERT ELCTRONIC STIMULATOR (K133929) | Shenzhen Osto Technology Company Limited | 2014-11-12 |
| ELECTRONIC PULSE STIMULATOR (K141260) | Shenzhen Jingkehui Electronic Co.., Ltd. | 2014-09-17 |
| EASYSTIM TN28_OTC (K140168) | Easymed Instruments Co., Ltd. | 2014-08-28 |
| TENS (K133979) | Sunmas (H.K.) Trading Limited | 2014-08-26 |
| IQ TECHNOLOGIES (K131290) | Iq Technologies, Inc. | 2014-08-06 |
| ASCEND (K140333) | Neurometrix, Inc. | 2014-07-03 |
| HIVOX ELECTRIC STIMULATOR OTC TENS (K140650) | Hivox Biotek, Inc. | 2014-06-27 |
| COUNTER OTC TENS DEVICE (K132993) | Counter Scientific Development (Gz), Ltd. | 2014-04-24 |
| PINOOK STIMULATOR (K132563) | Pinook USA | 2014-04-24 |
| QUICK RELAX PRO (K131956) | Healthcare Innovations, LLC | 2014-04-24 |
| OTC PATCH (K133723) | Well-Life Healthcare Limited | 2014-01-28 |
| MPP (K131910) | Marc Pro | 2014-01-24 |
| ELECTRONIC PULSE MASSAGER (K131933) | Gurin Products, LLC | 2013-12-20 |
| ELECTRONIC PULSE STIMULATOR (K131921) | Shenzhen Jingkehui Electronic Co.., Ltd. | 2013-11-15 |
| I RUNE (I-200L) (K122410) | Medirune Co, Ltd. | 2013-11-12 |
| TCM MASSAGER (K130150) | Anhui Jinjianqiao Med-Tech Co,. , Ltd. | 2013-09-26 |
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