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, Hivox Biotek, Inc. and Well-Life Healthcare Limited.
231
Total
231
Cleared
179d
Avg days
2004
Since
231 devices
Cleared
Oct 18, 2011
EVERYWAY LOW BACK PAIN RELIEF SYSTEM
Everyway Medical Instruments Co.,Ltd
Neurology
217d
Cleared
Aug 03, 2011
CARE BACK PAIN RELIEF STIMULATOR
Shenzhen Dongdixin Technology Co., Ltd.
Neurology
142d
Cleared
Jul 29, 2011
PAIN BUDDY
Biomedical Life Systems, Inc.
Neurology
373d
Cleared
May 13, 2011
HI-DOW-XP
Hi-Dow International, Inc.
Neurology
245d
Cleared
Jul 15, 2010
XINIWAVE, MODEL XW-18
International Trade Group, Inc.
Neurology
148d
Cleared
Apr 15, 2010
LASERTOUCHONE (OTC)
Laser Health Technologies, LLC
Neurology
90d
Cleared
Feb 05, 2010
OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407
Well-Life Healthcare Limited
Neurology
234d
Cleared
May 06, 2009
PAINMASTER MCT PATCH
Newmark, Inc.
Neurology
120d
Cleared
Dec 03, 2007
THERAPEUTIC MASSAGE COMPANION
Endurance Therapeutics
Neurology
615d
Cleared
May 24, 2007
RHYTHM TOUCH Q 2-WAY
Shockim Enterprises, Ltd.
Neurology
157d
Cleared
Feb 09, 2007
ELECTROPULSE - LOW BACK PAIN
Pain Relief Technologies
Neurology
165d
Cleared
Feb 07, 2007
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407
Well-Life Healthcare Limited
Neurology
61d
Cleared
Apr 28, 2006
LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP
Gemore Technology Co, Ltd.
Neurology
88d
Cleared
Mar 17, 2006
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406
Well-Life Healthcare Limited
Neurology
165d
Cleared
Aug 25, 2004
5000Z SYSTEM (OTC)
Prizm Medical, Inc.
Neurology
330d