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
145–168 of 229
Cleared Aug 11, 2017
EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only
K163166
Easywell Biomedicals, Inc.
Neurology · 270d
Cleared Aug 04, 2017
Hi-Dow Wireless TENS/EMS System (Model HD-5N)
K163393
Hi-Dow International, Inc.
Neurology · 245d
Cleared Jun 28, 2017
Livia
K163153
Lifecare , Ltd.
Neurology · 230d
Cleared May 26, 2017
IQ Technologies
K170659
Iq Technologies, Inc.
Neurology · 84d
Cleared May 12, 2017
Avazzia
K162392
Avazzia, Inc.
Neurology · 259d
Cleared May 11, 2017
Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
K170205
Shenzhen Kentro Medical Electronics Co., Ltd.
Neurology · 108d
Cleared Apr 29, 2017
Digital TENS Unit
K170145
Shenzhen Eapply Technology Co., Ltd.
Neurology · 102d
Cleared Apr 14, 2017
Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13
K162517
Jkh Health Co., Ltd.
Neurology · 217d
Cleared Feb 08, 2017
Smart Pain Reliever, Model LT5019
K162479
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 155d
Cleared Dec 20, 2016
CP Relief Wand-OTC
K162630
Mid-America Medical Innovations, LLC
Neurology · 90d
Cleared Dec 05, 2016
WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A
K161453
Well-Life Healthcare Limited
Neurology · 193d
Cleared Nov 21, 2016
Electronic Pulse Stimulator
K160508
Beijing Choice Electronic Technololgy Co., Ltd.
Neurology · 271d
Cleared Oct 13, 2016
OTC TENS Device, Model PTS-IV
K161537
Counter Scientific Development (Gz), Ltd.
Neurology · 132d
Cleared Oct 05, 2016
Painmaster MCT Patch
K151995
Newmark, Inc.
Neurology · 443d
Cleared Sep 15, 2016
HBOTC Muscle and Nerve Stimulator
K160255
Hb Medical, Inc.
Neurology · 227d
Cleared Jul 27, 2016
HANAROCare ReJu
K160893
M.I. Tech Co., Ltd.
Neurology · 118d
Cleared Jun 03, 2016
Heat Pain Pro
K160115
Omron Healthcare, Inc.
Neurology · 136d
Cleared May 20, 2016
CUR Model 1
K160052
Thimble Bioelectronics, Inc.
Neurology · 130d
Cleared May 05, 2016
Electronic Pulse Stimulator
K153520
Jkh Health Co., Ltd.
Neurology · 149d
Cleared Feb 12, 2016
Pain Therapy System, Model PTS-II
K150277
Counter Scientific Development (Gz), Ltd.
Neurology · 372d
Cleared Jan 13, 2016
LL TENS 160A, LL TENS 160B
K152374
Fuji Dynamics , Ltd.
Neurology · 145d
Cleared Jan 05, 2016
Quell
K152954
Neurometrix, Inc.
Neurology · 90d
Cleared Dec 23, 2015
2-in-1 Abdominal Muscle Training & Back Pain Relief System
K152128
Tohkai Precision Electrical Manufactory (Shenzhen) Limited
Neurology · 145d
Cleared Dec 22, 2015
ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)
K152852
Bayer Healthcare, LLC
Neurology · 84d