FDA Product Code NUH: Stimulator, Nerve, Transcutaneous, Over-the-counter
Over-the-counter nerve stimulators bring pain relief technology to the consumer market. FDA product code NUH covers transcutaneous electrical nerve stimulators available without a prescription.
These devices deliver low-level electrical impulses through skin electrodes to modulate pain signals for the temporary relief of sore or aching muscles. OTC TENS units are cleared for self-treatment of minor musculoskeletal pain in home settings.
NUH devices are Class II medical devices, regulated under 21 CFR 882.5890 and reviewed by the FDA Neurology panel.
Leading manufacturers include Everyway Medical Instruments Co.,Ltd, Shenzhen Kentro Medical Electronics Co., Ltd. and Hivox Biotek, Inc..
227
Total
227
Cleared
180d
Avg days
2004
Since
227 devices
Cleared
Jun 12, 2020
Electrical Stimulator System
Gymmax Technology Shenzen Co., Ltd.
Neurology
304d
Cleared
May 04, 2020
LIVIA
Lifecare , Ltd.
Neurology
543d
Cleared
Mar 14, 2020
Health Expert Electronic Stimulator (model: AST-300L)
Shenzhen Osto Technology Company Limited
Neurology
353d
Cleared
Dec 19, 2019
Everyway OTC TENS/EMS Combination
Everyway Medical Instruments Co.,Ltd
Neurology
90d
Cleared
Dec 12, 2019
Health Expert Electronic Stimulator
Shenzhen Osto Technology Company Limited
Neurology
272d
Cleared
Dec 02, 2019
Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
Hong Qiangxing (Shenzhen) Electronics Limited
Neurology
333d
Cleared
Nov 22, 2019
Healy
Timewaver Production GmbH
Neurology
213d
Cleared
Nov 01, 2019
Combo Electrotherapy Device
Shenzhen Roundwhale Technology Co. , Ltd.
Neurology
88d
Cleared
Oct 11, 2019
Electronic Pulse Stimulator
Shenzhen Leading Perfection Technology Co., Ltd.
Neurology
288d
Cleared
Oct 10, 2019
Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
Shenzhen Osto Technology Co., Ltd.
Neurology
430d
Cleared
Sep 21, 2019
Medi-Direct TENS Pen
Jkh USA, LLC
Neurology
360d
Cleared
Sep 07, 2019
Focus TENS Therapy, Model PM710-M/-L
Omron Healthcare, Inc.
Neurology
292d
Cleared
Aug 16, 2019
GIM-STIM OTC TENS/EMS System
Gemore Technology Co, Ltd.
Neurology
123d
Cleared
Aug 01, 2019
Mini TENS Therapy Device
Shenzhen Jumper Medical Equipment Co., Ltd.
Neurology
293d
Cleared
Jul 30, 2019
Transcutaneous Electrical Nerve Stimulator
Shenzhen Kentro Medical Electronics Co., Ltd.
Neurology
246d
Cleared
Jun 21, 2019
JKH Stimulator Plus
Jkh USA, LLC
Neurology
51d
Cleared
Jun 19, 2019
MHD TENS
Minghuangda Electronic Co., Ltd.
Neurology
146d
Cleared
Apr 26, 2019
Portable Electro-Stimulation Therapy Device
Guangzhou Longest Science & Technology Co., Ltd.
Neurology
266d
Cleared
Mar 15, 2019
HIVOX OTC Electrical Stimulator
Hivox Biotek, Inc.
Neurology
29d
Cleared
Mar 14, 2019
JKH Stimulator Plus
Jkh USA, LLC
Neurology
211d
Cleared
Feb 27, 2019
PAT (Pain Alleviation Technologies)
Marchan Medical, LLC
Neurology
190d
Cleared
Jan 10, 2019
Maxpower Relief
Omron Healthcare, Inc.
Neurology
157d
Cleared
Dec 07, 2018
Neck Care Therapy, Model: SYK 509B
Shenzhen Osto Technology Co., Ltd.
Neurology
441d
Cleared
Nov 26, 2018
Low-frequency Multi-function physiotherapy instrument
Shenzhen Osto Technology Co., Ltd.
Neurology
433d