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, Well-Life Healthcare Limited and Hivox Biotek, Inc..

229
Total
229
Cleared
180d
Avg days
2004
Since
229 devices
169–192 of 229
Cleared Dec 16, 2015
Counter OTC TENS Device, Model CSD-737Z
K151279
Counter Scientific Development (Gz), Ltd.
Neurology · 216d
Cleared Nov 21, 2015
PainKARE
K151034
Triowave Technologies
Neurology · 218d
Cleared Nov 05, 2015
Tyece OTC TENS Device
K150386
Tyece , Ltd.
Neurology · 260d
Cleared Oct 20, 2015
Palm TENS
K150308
Heat IN A Click, LLC
Neurology · 253d
Cleared Oct 16, 2015
EV-820 OTC Pain Relief TENS
K151479
Everyway Medical Instruments Co.,Ltd
Neurology · 136d
Cleared Aug 14, 2015
Transcutaneous Electrical Nerve Stimulators (TENS)
K150043
Andon Health Co, Ltd.
Neurology · 217d
Cleared Jul 21, 2015
TENS AND POWERED MUSCLE STIMULATOR
K143268
Shenzhen As-Tec Technology Co., Ltd.
Neurology · 250d
Cleared Jul 21, 2015
PulseRelief
K151035
Philips Consumer Lifestyle
Neurology · 95d
Cleared Jul 06, 2015
Electronic Pulse Stimulator
K150995
Shenzhen Jingkehui Electronic Co.., Ltd.
Neurology · 82d
Cleared May 29, 2015
SmartTENS
K143430
Easy Med Instrument Co., Ltd.
Neurology · 179d
Cleared May 12, 2015
GEMORE OTC TENS
K150681
Gemore Technology Co, Ltd.
Neurology · 56d
Cleared Mar 04, 2015
DOLPHIN NEUROSTIM OTC
K133789
Acumed Medical , Ltd.
Neurology · 447d
Cleared Dec 18, 2014
StimPad OTC
K142686
Aemed, Inc.
Neurology · 87d
Cleared Dec 03, 2014
5000Z FIREFLY SYSTEM
K133502
Prizm Medical, Inc.
Neurology · 384d
Cleared Dec 03, 2014
MAXPOWER RELIEF
K141978
Omron Healthcare, Inc.
Neurology · 135d
Cleared Nov 14, 2014
OTC COMBO TENS/EMS SYSTEM
K141299
Well-Life Healthcare Limited
Neurology · 179d
Cleared Nov 12, 2014
HEALTH EXPERT ELCTRONIC STIMULATOR
K133929
Shenzhen Osto Technology Company Limited
Neurology · 324d
Cleared Sep 17, 2014
ELECTRONIC PULSE STIMULATOR
K141260
Shenzhen Jingkehui Electronic Co.., Ltd.
Neurology · 125d
Cleared Aug 28, 2014
EASYSTIM TN28_OTC
K140168
Easymed Instruments Co., Ltd.
Neurology · 217d
Cleared Aug 26, 2014
TENS
K133979
Sunmas (H.K.) Trading Limited
Neurology · 243d
Cleared Aug 06, 2014
IQ TECHNOLOGIES
K131290
Iq Technologies, Inc.
Neurology · 457d
Cleared Jul 03, 2014
ASCEND
K140333
Neurometrix, Inc.
Neurology · 143d
Cleared Jun 27, 2014
HIVOX ELECTRIC STIMULATOR OTC TENS
K140650
Hivox Biotek, Inc.
Neurology · 106d
Cleared Apr 24, 2014
QUICK RELAX PRO
K131956
Healthcare Innovations, LLC
Neurology · 301d