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

231
Total
231
Cleared
179d
Avg days
2004
Since
231 devices
217–231 of 231
Cleared Oct 18, 2011
EVERYWAY LOW BACK PAIN RELIEF SYSTEM
K110716
Everyway Medical Instruments Co.,Ltd
Neurology · 217d
Cleared Aug 03, 2011
CARE BACK PAIN RELIEF STIMULATOR
K110707
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 142d
Cleared Jul 29, 2011
PAIN BUDDY
K102051
Biomedical Life Systems, Inc.
Neurology · 373d
Cleared May 13, 2011
HI-DOW-XP
K102598
Hi-Dow International, Inc.
Neurology · 245d
Cleared Jul 15, 2010
XINIWAVE, MODEL XW-18
K100441
International Trade Group, Inc.
Neurology · 148d
Cleared Apr 15, 2010
LASERTOUCHONE (OTC)
K100116
Laser Health Technologies, LLC
Neurology · 90d
Cleared Feb 05, 2010
OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407
K091757
Well-Life Healthcare Limited
Neurology · 234d
Cleared May 06, 2009
PAINMASTER MCT PATCH
K090042
Newmark, Inc.
Neurology · 120d
Cleared Dec 03, 2007
THERAPEUTIC MASSAGE COMPANION
K060846
Endurance Therapeutics
Neurology · 615d
Cleared May 24, 2007
RHYTHM TOUCH Q 2-WAY
K063743
Shockim Enterprises, Ltd.
Neurology · 157d
Cleared Feb 09, 2007
ELECTROPULSE - LOW BACK PAIN
K062532
Pain Relief Technologies
Neurology · 165d
Cleared Feb 07, 2007
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407
K063660
Well-Life Healthcare Limited
Neurology · 61d
Cleared Apr 28, 2006
LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP
K060222
Gemore Technology Co, Ltd.
Neurology · 88d
Cleared Mar 17, 2006
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406
K052785
Well-Life Healthcare Limited
Neurology · 165d
Cleared Aug 25, 2004
5000Z SYSTEM (OTC)
K033122
Prizm Medical, Inc.
Neurology · 330d