NUH

Stimulator, Nerve, Transcutaneous, Over-The-Counter

产品代码
NUH
器械名称
Stimulator, Nerve, Transcutaneous, Over-The-Counter
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 882.5890
FDA 专业组
Neurology
上市路径
需提交 510(k) 上市前通告
标记
可走第三方审查
该代码近三年的 510(k)
229 件

FDA 分类定义

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

定义原文来自 FDA 器械分类库,属美国联邦政府作品(公有领域)。

该代码近三年的 510(k)(42 件)

数据窗口为最近三年。最新一件:2026-06-26。

510(k) 号批准日期申请人器械名称摘要
K2604122026-06-26Shenzhen Dongdixin Technology Co., LtdTENS 7000 Rechargeable 4 Channel (TENS 7000H)
K2604252026-06-16Hivox Biotek, Inc.TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
K2538962026-03-04Globalcare Medical Technology Co., LtdTENS/EMS device (GUSE01)PDF
K2533052025-12-31Shenzhen Jiantuo Electronics Co., Ltd.TENS AND EMS (TENS and Muscle Stimulator) (JT1065, J
K2537402025-12-23Hong Qiangxing (Shenzhen) Electronics TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
K2519582025-12-23Dynapulse MedicalVEINOPLUS BackPDF
K2526882025-11-24Bozhou Rongjian Medical Appliance Co.,Transcutaneous Electrical Nerve Stimulator (RJTENS-2PDF
K2518562025-11-21Everyway Medical Instruments Co.,LtdLi-Battery Powered OTC TENS/EMS Combination StimulatPDF
K2431312025-11-07Sigma BiomedicalTriathlon ProPDF
K2514292025-08-28Changsha Anxiang Medical Technology CoOTC 4-Channel Rechargeable TENS Unit
K2507842025-08-21Shenzhen Yicai Health Technology Co., Transcutaneous Electrical Nerve Stimulator ( K6133/
K2511872025-07-28Changsha Anxiang Medical Technology Co3 in 1 TENS UNIT (TC1241, TC2241, TS1241)
K2438562025-05-29Shenzhen Astec Technology Co., Ltd.TENS AND EMS (TENS and Muscle Stimulator) ( Model AS
K2503602025-05-11Shenzhen Jiantuo Electronics Co., Ltd.TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,J
K2500532025-05-09Shenzhen Jiantuo Electronics Co., Ltd.TENS AND EMS (TENS and Muscle Stimulator) (JT8012, J
K2436132025-04-09Transtimulation Research, Inc.Patch-TEA (Model TRI-21)PDF
K2500332025-04-07Guangzhou Pinzhi Medical Technology CoSmart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)
K2424602025-04-02Progenix, LLCProgenix Select StimPDF
K2428152024-12-17Hivox Biotek, Inc.POCKET TENS (EP-300)PDF
K2433342024-11-22Xf Agencija LimitedNooro Body & Foot Stimulator (SM9141, SM9142)
K2423322024-11-05Shenzhen Kentro Medical Electronics CoTranscutaneous Electronic Nerve Stimulator (KTR-230
K2425672024-11-04Changsha Anxiang Medical Technology CoMuscle and Nerve Stimulator TENS & EMS (TP2208), Mus
K2330542024-10-18Well-Life Healthcare LimitedWell-Life Pain Relief (Menstrual Plus) Electrical StPDF
K2416782024-09-09Shenzhen Minghuangda Electronics Co., TENS & EMS Stimulator (MHD-1083)PDF
K2413652024-08-12Pixie Cup, LLCPixie Pulse (SM9068)
K2411192024-07-22Shenzhen Yicai Health Technology Co., Transcutaneous Electrical Nerve Stimulator (K6106)PDF
K2330672024-07-19Chongqing Rob Linka Science and TechnoWireless TENS & EMS (Model SM9110,SM9113,SM9116)
K2415092024-06-27Plexus Yoga, LLC Dba ChirpTENS&EMS units (SM9109A, SM9109B)
K2314252024-03-27Wuxi Jiajian Medical Instrument Co., LTranscutaneous Electrical Nerve Stimulator (TENS WMPPDF
K2402922024-03-25Hong Kong Etech Groups LimitedTranscutaneous Electrical Nerve Stimulator (9029SCM)PDF
K2324392024-03-21Gymmax Technology Shenzen Co., Ltd.Electrical Stimulator SystemPDF
K2330952024-03-01Micro Current Technology, Inc.S21 OTC Transcutaneous Electrical Nerve Stimulator
K2316482024-03-01Shenzhen Yiran Intelligent Co., Ltd.Muscle StimulatorPDF
K2337842024-02-23Hinge Health, Inc.ENSO (Model 2)PDF
K2330402024-02-12Shenzhen Imdk Medical Technology Co., EMS/TENS Massager Device
K2330922024-02-12Chongqing Rob Linka Science and TechnoPain Therapy Device (SM9075, SM9910, SM9067, SM9587W
K2314232024-01-22Shenzhen Roundwhale Technology Co. , LCombo Electrotherapy Device (Models: R-C101C, R-C101PDF
K2334612024-01-19Hi-Dow International, Inc.Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)
K2309262023-12-15Tenscare, Ltd.Ova+ (K-OVAP-USA)FDA
K2325172023-12-08Shenzhen Kentro Medical Electronics CoTranscutaneous Electrical Nerve Stimulator For Pain
K2315692023-11-03Manamed, Inc.ManaFlexx 2 (model: MF002-RX, MF002-OTC)PDF
K2326752023-10-05Hivox Biotek, Inc.Heating Tens, FT-615PDF

其中 19 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

FDA 官方分类页: NUH
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。