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 |
|---|---|---|---|
| Jun 12, 2020 | K192201 | Electrical Stimulator System Gymmax Technology Shenzen Co., Ltd., CN | NUH |
| May 4, 2020 | K183110 | LIVIA Lifecare , Ltd., IL | NUH |
| Mar 14, 2020 | K190783 | Health Expert Electronic Stimulator (model: AST-300L) Shenzhen Osto Technology Company Limited, CN | NUH |
| Dec 19, 2019 | K192589 | Everyway OTC TENS/EMS Combination Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Dec 12, 2019 | K190673 | Health Expert Electronic Stimulator Shenzhen Osto Technology Company Limited, CN | NUH |
| Dec 2, 2019 | K190009 | Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) Hong Qiangxing (Shenzhen) Electronics Limited, CN | NUH |
| Nov 22, 2019 | K191075 | Healy Timewaver Production GmbH, DE | NUH |
| Nov 1, 2019 | K192087 | Combo Electrotherapy Device Shenzhen Roundwhale Technology Co. , Ltd., CN | NUH |
| Oct 11, 2019 | K183674 | Electronic Pulse Stimulator Shenzhen Leading Perfection Technology Co., Ltd., CN | NUH |
| Oct 10, 2019 | K182136 | Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) Shenzhen Osto Technology Co., Ltd., CN | NUH |
| Sep 21, 2019 | K182671 | Medi-Direct TENS Pen Jkh USA, LLC | NUH |
| Sep 7, 2019 | K183215 | Focus TENS Therapy, Model PM710-M/-L Omron Healthcare, Inc. | NUH |
| Aug 16, 2019 | K190988 | GIM-STIM OTC TENS/EMS System Gemore Technology Co, Ltd., TW | NUH |
| Aug 1, 2019 | K182871 | Mini TENS Therapy Device Shenzhen Jumper Medical Equipment Co., Ltd., CN | NUH |
| Jul 30, 2019 | K183288 | Transcutaneous Electrical Nerve Stimulator Shenzhen Kentro Medical Electronics Co., Ltd., CN | NUH |
| Jun 21, 2019 | K191151 | JKH Stimulator Plus Jkh USA, LLC | NUH |
| Jun 19, 2019 | K190115 | MHD TENS Minghuangda Electronic Co., Ltd., CN | NUH |
| Apr 26, 2019 | K182108 | Portable Electro-Stimulation Therapy Device Guangzhou Longest Science & Technology Co., Ltd., CN | NUH |
| Mar 15, 2019 | K190347 | HIVOX OTC Electrical Stimulator Hivox Biotek, Inc., TW | NUH |
| Mar 14, 2019 | K182203 | JKH Stimulator Plus Jkh USA, LLC | NUH |
| Feb 27, 2019 | K182267 | PAT (Pain Alleviation Technologies) Marchan Medical, LLC | NUH |
| Jan 10, 2019 | K182120 | Maxpower Relief Omron Healthcare, Inc. | NUH |
| Dec 7, 2018 | K172897 | Neck Care Therapy, Model: SYK 509B Shenzhen Osto Technology Co., Ltd., CN | NUH |
| Nov 26, 2018 | K172837 | Low-frequency Multi-function physiotherapy instrument Shenzhen Osto Technology Co., Ltd., CN | NUH |
| Nov 21, 2018 | K182581 | PlayMakar Sport Muscle Stimulator, Model PRO-500 Playmakar, Inc. | NUH |
| Nov 9, 2018 | K181992 | Heat Pain Pro Omron Healthcare, Inc. | NUH |
| Oct 26, 2018 | K182767 | V2 OTC Pain Relief TENS Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Oct 26, 2018 | K182753 | A6 OTC Pain Relief TENS Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Sep 26, 2018 | K181707 | Everyway Wireless TENS & EMS Unit Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Sep 15, 2018 | K181102 | ThermaCare Quick Therapy TENS Pfizer, Inc. | NUH |
| Sep 6, 2018 | K172834 | Dual output digital therapy massager Shenzhen Osto Technology Co., Ltd., CN | NUH |
| Aug 10, 2018 | K181849 | iStim S2 OTC Pain Relief TENS Everyway Medical Instruments Co., Ldt., TW | NUH |
| Jul 8, 2018 | K172971 | BMLS16-1 Biomedical Life Systems, Inc. | NUH |
| Jun 22, 2018 | K180331 | Wireless Pain Relieve Device Shenzhen Dongdixin Technology Co., Ltd., CN | NUH |
| Jun 7, 2018 | K180956 | Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator Shenzhen Roundwhale Technology Co. , Ltd., CN | NUH |
| Jun 6, 2018 | K181207 | Balego TENS Digital Edition with Accessories for Pain Relief (OTC) Everyway Medical Instruments Co., Ldt., TW | NUH |
| Apr 19, 2018 | K172919 | EV-804 OTC Pain Relief TENS Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Mar 7, 2018 | K171802 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) Bayer Healthcare, LLC | NUH |
| Dec 8, 2017 | K173462 | Wireless Pain Relieve Device Model: LT5018C Shenzhen Dongdixin Technology Co., Ltd., CN | NUH |
| Nov 29, 2017 | K171803 | HIVOX OTC Electrical Stimulator Hivox Biotek, Inc., TW | NUH |
| Nov 17, 2017 | K172451 | Dr.MUSIC 3s Smartmedicaldevice Co., Ltd., KR | NUH |
| Nov 1, 2017 | K171026 | Mytens Model: BW-TSX Bewell Connect Corp. | NUH |
| Oct 19, 2017 | K172079 | Avail Omron Healthcare, Inc. | NUH |
| Oct 18, 2017 | K172809 | OTC Combo TENS/EMS System Well-Life Healthcare Limited, TW | NUH |
| Sep 22, 2017 | K171599 | WiTouch Pro, WiTouch, Neubac Hollywog, LLC | NUH |
| Sep 19, 2017 | K163611 | Pain Therapy Device Guangzhou Xinbo Electronic Co., Ltd., CN | NUH |
| Aug 11, 2017 | K163166 | EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only Easywell Biomedicals, Inc., TW | NUH |
| Aug 4, 2017 | K163393 | Hi-Dow Wireless TENS/EMS System (Model HD-5N) Hi-Dow International, Inc. | NUH |
| Jun 28, 2017 | K163153 | Livia Lifecare , Ltd., IL | NUH |
| May 26, 2017 | K170659 | IQ Technologies Iq Technologies, Inc. | NUH |
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