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, Well-Life Healthcare Limited and Hivox Biotek, Inc..
229
Total
229
Cleared
180d
Avg days
2004
Since
229 devices
Cleared
Dec 16, 2015
Counter OTC TENS Device, Model CSD-737Z
Counter Scientific Development (Gz), Ltd.
Neurology
216d
Cleared
Nov 21, 2015
PainKARE
Triowave Technologies
Neurology
218d
Cleared
Nov 05, 2015
Tyece OTC TENS Device
Tyece , Ltd.
Neurology
260d
Cleared
Oct 20, 2015
Palm TENS
Heat IN A Click, LLC
Neurology
253d
Cleared
Oct 16, 2015
EV-820 OTC Pain Relief TENS
Everyway Medical Instruments Co.,Ltd
Neurology
136d
Cleared
Aug 14, 2015
Transcutaneous Electrical Nerve Stimulators (TENS)
Andon Health Co, Ltd.
Neurology
217d
Cleared
Jul 21, 2015
TENS AND POWERED MUSCLE STIMULATOR
Shenzhen As-Tec Technology Co., Ltd.
Neurology
250d
Cleared
Jul 21, 2015
PulseRelief
Philips Consumer Lifestyle
Neurology
95d
Cleared
Jul 06, 2015
Electronic Pulse Stimulator
Shenzhen Jingkehui Electronic Co.., Ltd.
Neurology
82d
Cleared
May 29, 2015
SmartTENS
Easy Med Instrument Co., Ltd.
Neurology
179d
Cleared
May 12, 2015
GEMORE OTC TENS
Gemore Technology Co, Ltd.
Neurology
56d
Cleared
Mar 04, 2015
DOLPHIN NEUROSTIM OTC
Acumed Medical , Ltd.
Neurology
447d
Cleared
Dec 18, 2014
StimPad OTC
Aemed, Inc.
Neurology
87d
Cleared
Dec 03, 2014
5000Z FIREFLY SYSTEM
Prizm Medical, Inc.
Neurology
384d
Cleared
Dec 03, 2014
MAXPOWER RELIEF
Omron Healthcare, Inc.
Neurology
135d
Cleared
Nov 14, 2014
OTC COMBO TENS/EMS SYSTEM
Well-Life Healthcare Limited
Neurology
179d
Cleared
Nov 12, 2014
HEALTH EXPERT ELCTRONIC STIMULATOR
Shenzhen Osto Technology Company Limited
Neurology
324d
Cleared
Sep 17, 2014
ELECTRONIC PULSE STIMULATOR
Shenzhen Jingkehui Electronic Co.., Ltd.
Neurology
125d
Cleared
Aug 28, 2014
EASYSTIM TN28_OTC
Easymed Instruments Co., Ltd.
Neurology
217d
Cleared
Aug 26, 2014
TENS
Sunmas (H.K.) Trading Limited
Neurology
243d
Cleared
Aug 06, 2014
IQ TECHNOLOGIES
Iq Technologies, Inc.
Neurology
457d
Cleared
Jul 03, 2014
ASCEND
Neurometrix, Inc.
Neurology
143d
Cleared
Jun 27, 2014
HIVOX ELECTRIC STIMULATOR OTC TENS
Hivox Biotek, Inc.
Neurology
106d
Cleared
Apr 24, 2014
QUICK RELAX PRO
Healthcare Innovations, LLC
Neurology
301d