Stimulator, Nerve, Transcutaneous, Over-The-Counter
Regulation 882.5890
11510(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 |
|---|---|---|---|
| Oct 16, 2026 | K261574 | Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) Hong Qiangxing (Shenzhen) Electronics Limited, CN | NUH |
| Sep 6, 2026 | K261131 | Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-30 Shenzhen Osto Medical Technology Co.,Ltd, CN | NUH |
| Jun 26, 2026 | K260412 | TENS 7000 Rechargeable 4 Channel (TENS 7000H) Shenzhen Dongdixin Technology Co., Ltd., CN | NUH |
| Jun 16, 2026 | K260425 | TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) Hivox Biotek, Inc., TW | NUH |
| Mar 4, 2026 | K253896 | TENS/EMS device (GUSE01) Globalcare Medical Technology Co., Ltd., CN | NUH |
| Dec 31, 2025 | K253305 | TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) Shenzhen Jiantuo Electronics Co., Ltd., CN | NUH |
| Dec 23, 2025 | K253740 | TENS&EMS (HZ9151B, HZ9151C, HZ9151D) Hong Qiangxing (Shenzhen) Electronics Limited, CN | NUH |
| Dec 23, 2025 | K251958 | VEINOPLUS Back Dynapulse Medical | NUH |
| Nov 24, 2025 | K252688 | Transcutaneous Electrical Nerve Stimulator (RJTENS-2) Bozhou Rongjian Medical Appliance Co., Ltd., CN | NUH |
| Nov 21, 2025 | K251856 | Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Nov 7, 2025 | K243131 | Triathlon Pro Sigma Biomedical | NUH |
| Aug 28, 2025 | K251429 | OTC 4-Channel Rechargeable TENS Unit Changsha Anxiang Medical Technology Co., Ltd., CN | NUH |
| Aug 21, 2025 | K250784 | Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143 Shenzhen Yicai Health Technology Co., Ltd., CN | NUH |
| Jul 28, 2025 | K251187 | 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) Changsha Anxiang Medical Technology Co., Ltd., CN | NUH |
| May 29, 2025 | K243856 | TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026) Shenzhen Astec Technology Co., Ltd., CN | NUH |
| May 11, 2025 | K250360 | TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026) Shenzhen Jiantuo Electronics Co., Ltd., CN | NUH |
| May 9, 2025 | K250053 | TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) Shenzhen Jiantuo Electronics Co., Ltd., CN | NUH |
| Apr 9, 2025 | K243613 | Patch-TEA (Model TRI-21) Transtimulation Research, Inc. | NUH |
| Apr 7, 2025 | K250033 | Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) Guangzhou Pinzhi Medical Technology Co., Ltd., CN | NUH |
| Apr 2, 2025 | K242460 | Progenix Select Stim Progenix, LLC | NUH |
| Dec 17, 2024 | K242815 | POCKET TENS (EP-300) Hivox Biotek, Inc., TW | NUH |
| Nov 22, 2024 | K243334 | Nooro Body & Foot Stimulator (SM9141, SM9142) Xf Agencija Limited, CN | NUH |
| Nov 5, 2024 | K242332 | Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2 Shenzhen Kentro Medical Electronics Co., Ltd., CN | NUH |
| Nov 4, 2024 | K242567 | Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C) Changsha Anxiang Medical Technology Co., Ltd., CN | NUH |
| Oct 18, 2024 | K233054 | Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Well-Life Healthcare Limited, TW | NUH |
| Sep 9, 2024 | K241678 | TENS & EMS Stimulator (MHD-1083) Shenzhen Minghuangda Electronics Co., Ltd., CN | NUH |
| Aug 12, 2024 | K241365 | Pixie Pulse (SM9068) Pixie Cup, LLC | NUH |
| Jul 22, 2024 | K241119 | Transcutaneous Electrical Nerve Stimulator (K6106) Shenzhen Yicai Health Technology Co., Ltd., CN | NUH |
| Jul 19, 2024 | K233067 | Wireless TENS & EMS (Model SM9110,SM9113,SM9116) Chongqing Rob Linka Science and Technology Co., Ltd., CN | NUH |
| Jun 27, 2024 | K241509 | TENS&EMS units (SM9109A, SM9109B) Plexus Yoga, LLC Dba Chirp | NUH |
| Mar 27, 2024 | K231425 | Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) Wuxi Jiajian Medical Instrument Co., Ltd., CN | NUH |
| Mar 25, 2024 | K240292 | Transcutaneous Electrical Nerve Stimulator (9029SCM) Hong Kong Etech Groups Limited, CN | NUH |
| Mar 21, 2024 | K232439 | Electrical Stimulator System Gymmax Technology Shenzen Co., Ltd., CN | NUH |
| Mar 1, 2024 | K233095 | S21 OTC Transcutaneous Electrical Nerve Stimulator Micro Current Technology, Inc. | NUH |
| Mar 1, 2024 | K231648 | Muscle Stimulator Shenzhen Yiran Intelligent Co., Ltd., CN | NUH |
| Feb 23, 2024 | K233784 | ENSO (Model 2) Hinge Health, Inc. | NUH |
| Feb 12, 2024 | K233092 | Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) Chongqing Rob Linka Science and Technology Co., Ltd., CN | NUH |
| Feb 12, 2024 | K233040 | EMS/TENS Massager Device Shenzhen Imdk Medical Technology Co., Ltd., CN | NUH |
| Jan 22, 2024 | K231423 | Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) Shenzhen Roundwhale Technology Co. , Ltd., CN | NUH |
| Jan 19, 2024 | K233461 | Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) Hi-Dow International, Inc. | NUH |
| Dec 15, 2023 | K230926 | Ova+ (K-OVAP-USA) Tenscare, Ltd., GB | NUH |
| Dec 8, 2023 | K232517 | Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412) Shenzhen Kentro Medical Electronics Co., Ltd., CN | NUH |
| Nov 3, 2023 | K231569 | ManaFlexx 2 (model: MF002-RX, MF002-OTC) Manamed, Inc. | NUH |
| Oct 5, 2023 | K232675 | Heating Tens, FT-615 Hivox Biotek, Inc., TW | NUH |
| Aug 18, 2023 | K231053 | Unicare (K-UNICARE-USA) Tenscare, Ltd., GB | NUH |
| Jul 19, 2023 | K223151 | Nu-beca Transcutaneous Electrical Nerve Stimulation Nu-Beca & Maxcellent Co., TW | NUH |
| May 22, 2023 | K230443 | TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) Jiangxi Royall Smart Technology Co., Ltd., CN | NUH |
| May 13, 2023 | K223308 | HEATING TENS/EMS, FT-810R Hivox Biotek, Inc., TW | NUH |
| May 10, 2023 | K222870 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, Shenzhen Kentro Medical Electronics Co., Ltd., CN | NUH |
| May 9, 2023 | K223825 | Tens & Ems Device Shenzhen Jian Feng Electronic Technology Co., Ltd., CN | NUH |
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