NUH · Class II · 21 CFR 882.5890

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
97–120 of 227
Cleared Jun 12, 2020
Electrical Stimulator System
K192201
Gymmax Technology Shenzen Co., Ltd.
Neurology · 304d
Cleared May 04, 2020
LIVIA
K183110
Lifecare , Ltd.
Neurology · 543d
Cleared Mar 14, 2020
Health Expert Electronic Stimulator (model: AST-300L)
K190783
Shenzhen Osto Technology Company Limited
Neurology · 353d
Cleared Dec 19, 2019
Everyway OTC TENS/EMS Combination
K192589
Everyway Medical Instruments Co.,Ltd
Neurology · 90d
Cleared Dec 12, 2019
Health Expert Electronic Stimulator
K190673
Shenzhen Osto Technology Company Limited
Neurology · 272d
Cleared Dec 02, 2019
Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
K190009
Hong Qiangxing (Shenzhen) Electronics Limited
Neurology · 333d
Cleared Nov 22, 2019
Healy
K191075
Timewaver Production GmbH
Neurology · 213d
Cleared Nov 01, 2019
Combo Electrotherapy Device
K192087
Shenzhen Roundwhale Technology Co. , Ltd.
Neurology · 88d
Cleared Oct 11, 2019
Electronic Pulse Stimulator
K183674
Shenzhen Leading Perfection Technology Co., Ltd.
Neurology · 288d
Cleared Oct 10, 2019
Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
K182136
Shenzhen Osto Technology Co., Ltd.
Neurology · 430d
Cleared Sep 21, 2019
Medi-Direct TENS Pen
K182671
Jkh USA, LLC
Neurology · 360d
Cleared Sep 07, 2019
Focus TENS Therapy, Model PM710-M/-L
K183215
Omron Healthcare, Inc.
Neurology · 292d
Cleared Aug 16, 2019
GIM-STIM OTC TENS/EMS System
K190988
Gemore Technology Co, Ltd.
Neurology · 123d
Cleared Aug 01, 2019
Mini TENS Therapy Device
K182871
Shenzhen Jumper Medical Equipment Co., Ltd.
Neurology · 293d
Cleared Jul 30, 2019
Transcutaneous Electrical Nerve Stimulator
K183288
Shenzhen Kentro Medical Electronics Co., Ltd.
Neurology · 246d
Cleared Jun 21, 2019
JKH Stimulator Plus
K191151
Jkh USA, LLC
Neurology · 51d
Cleared Jun 19, 2019
MHD TENS
K190115
Minghuangda Electronic Co., Ltd.
Neurology · 146d
Cleared Apr 26, 2019
Portable Electro-Stimulation Therapy Device
K182108
Guangzhou Longest Science & Technology Co., Ltd.
Neurology · 266d
Cleared Mar 15, 2019
HIVOX OTC Electrical Stimulator
K190347
Hivox Biotek, Inc.
Neurology · 29d
Cleared Mar 14, 2019
JKH Stimulator Plus
K182203
Jkh USA, LLC
Neurology · 211d
Cleared Feb 27, 2019
PAT (Pain Alleviation Technologies)
K182267
Marchan Medical, LLC
Neurology · 190d
Cleared Jan 10, 2019
Maxpower Relief
K182120
Omron Healthcare, Inc.
Neurology · 157d
Cleared Dec 07, 2018
Neck Care Therapy, Model: SYK 509B
K172897
Shenzhen Osto Technology Co., Ltd.
Neurology · 441d
Cleared Nov 26, 2018
Low-frequency Multi-function physiotherapy instrument
K172837
Shenzhen Osto Technology Co., Ltd.
Neurology · 433d