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