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 8, 2023 | K223428 | Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, u Shenzhen Leqing Medical Instrument Co., Ltd., CN | NUH |
| Apr 26, 2023 | K230829 | TENS7000 Rechargeable (Model:TENS7000 Rechargeable) Chongqing Rob Linka Science and Technology Co., Ltd., CN | NUH |
| Apr 10, 2023 | K230164 | TENS and EMS Stimulation (OTC) Changsha Yuwen Medical Equipment Co., Ltd., CN | NUH |
| Mar 20, 2023 | K230174 | TENS and EMS Stimulation (OTC) Changsha Yuwen Medical Equipment Co., Ltd., CN | NUH |
| Mar 20, 2023 | K230163 | TENS and EMS Stimulation (OTC) Changsha Yuwen Medical Equipment Co., Ltd., CN | NUH |
| Dec 21, 2022 | K222867 | AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) Andon Health Co, Ltd., CN | NUH |
| Nov 15, 2022 | K222488 | Everyway Analog OTC TENS Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Oct 21, 2022 | K221992 | Electronic Pulse Stimulator Beijing Choice Electronic Technology Co., Ltd., CN | NUH |
| Sep 13, 2022 | K221092 | Transcutaneous Electrical Nerve Stimulator Model: ST-304 Shenzhen Future Electronic Co., Ltd., CN | NUH |
| Sep 1, 2022 | K220997 | Wireless TENS/EMS, Bruno, Aela Zmi Elecronics , Ltd., TW | NUH |
| Aug 24, 2022 | K220998 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 Shenzhen Kentro Medical Electronics Co., Ltd., CN | NUH |
| Aug 4, 2022 | K220524 | Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series) Well-Life Healthcare Limited, TW | NUH |
| Jul 29, 2022 | K221251 | Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) Guangzhou Huakai Electronic Technology Co., Ltd., CN | NUH |
| Jul 9, 2022 | K220573 | Noodle Pourang Bral, Dds, LLC | NUH |
| Jun 11, 2022 | K221384 | Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 Hivox Biotek, Inc., TW | NUH |
| May 6, 2022 | K213788 | TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) Dongguan Bohuikang Technology Co.,Ltd, CN | NUH |
| May 2, 2022 | K220283 | TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) Hong Qiangxing (Shenzhen) Electronics Limited, CN | NUH |
| Apr 19, 2022 | K220152 | TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) Hong Qiangxing (Shenzhen) Electronics Limited, CN | NUH |
| Apr 15, 2022 | K212377 | Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 Ningbo Medkinetic Medical Device Co., Ltd., CN | NUH |
| Apr 1, 2022 | K220005 | TENS & PMS Unit Shenzhen Yuehua Xinsen Technology Co., Ltd., CN | NUH |
| Apr 1, 2022 | K212184 | TENS and EMS Stimulation (OTC) Changsha Yuwen Medical Equipment Co., Ltd., CN | NUH |
| Mar 8, 2022 | K213741 | TENS & EMS DEVICE (Model: FM-B2403A) Shenzhen Jian Feng Electronic Technology Co., Ltd., CN | NUH |
| Mar 3, 2022 | K213835 | TENS & EMS Device Shenzhen Jian Feng Electronic Technology Co., Ltd., CN | NUH |
| Feb 19, 2022 | K213091 | Well-Life TENS/EMS/Heating Stimulator Well-Life Healthcare Limited, TW | NUH |
| Feb 17, 2022 | K220150 | TENS & PMS (Model: SM9126) Hong Qiangxing (Shenzhen) Electronics Limited, CN | NUH |
| Dec 30, 2021 | K211263 | Intrelief Easymed Instruments Co., Ltd., CN | NUH |
| Dec 22, 2021 | K212285 | Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android) Oriental Inspiration Limited, CN | NUH |
| Dec 15, 2021 | K210223 | Transcutaneous Electrical Nerve Stimulator Top-Rank Health Care Co., Ltd., CN | NUH |
| Dec 13, 2021 | K212918 | Heat StimPlus Famidoc Technology Co., Ltd., CN | NUH |
| Nov 22, 2021 | K212989 | Low-frequency Stimulator (Model: AST-645, AST-646) Shenzhen Osto Technology Co., Ltd., CN | NUH |
| Nov 12, 2021 | K202671 | DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) Guangzhou Xinbo Electronic Co., Ltd., CN | NUH |
| Oct 15, 2021 | K211403 | HIVOX OTC Electrical Stimulator, FT610-B Hivox Biotek, Inc., TW | NUH |
| Oct 4, 2021 | K200558 | Smart Neck Stimulator Guandong Skg Intelligent Technology Co., Ltd., CN | NUH |
| Sep 5, 2021 | K211736 | Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) Shenzhen Osto Technology Company Limited, CN | NUH |
| Jun 11, 2021 | K210756 | Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H Shenzhen Osto Technology Company Limited, CN | NUH |
| Jun 4, 2021 | K200694 | Perfect EMS Tenscare, Ltd., GB | NUH |
| May 19, 2021 | K202866 | TENS & EMS Device Shenzhen Jian Feng Electronic Technology Co., Ltd., CN | NUH |
| Mar 25, 2021 | K200177 | Low-frequency Multi-function physiotherapy instrument Shenzhen Kentro Medical Electronics Co., Ltd., CN | NUH |
| Mar 10, 2021 | K203574 | HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 Hivox Biotek, Inc., TW | NUH |
| Dec 22, 2020 | K202849 | Everyway Analog OTC TENS, model N103A/N302 Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Nov 25, 2020 | K202470 | Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 Everyway Medical Instruments Co.,Ltd, CN | NUH |
| Nov 13, 2020 | K202317 | Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 Everyway Medical Instruments Co.,Ltd, CN | NUH |
| Oct 24, 2020 | K201335 | Li-Battery powered OTC TENS/EMS Combination Stimulator Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Oct 19, 2020 | K200237 | Transcutaneous Electronic Nerve Stimulator Shenzhen Kentro Medical Electronics Co., Ltd., CN | NUH |
| Sep 25, 2020 | K191982 | Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211 Shenzhen Kentro Medical Electronics Co., Ltd., CN | NUH |
| Sep 4, 2020 | K193655 | MSLS6QF TENS/PMS Device Self Doctor Care, LLC | NUH |
| Aug 12, 2020 | K200838 | Tyece OTC TENS Model Tyece Limited, CN | NUH |
| Jul 1, 2020 | K200561 | StimPlus Patch, StimPlus Patch, StimPlus Patch Jkh Health Co., Ltd., CN | NUH |
| Jun 29, 2020 | K200354 | Electronic stimulator Shenzhen Dongjilian Electronics Co., Ltd., CN | NUH |
| Jun 18, 2020 | K200727 | TENS and Muscle Stimulator Shenzhen Astec Technology Co., Ltd., CN | NUH |
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