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
Jul 29, 2011
PAIN BUDDY
Biomedical Life Systems, Inc.
Neurology
373d
Cleared
Feb 05, 2010
OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407
Well-Life Healthcare Limited
Neurology
234d
Cleared
Feb 07, 2007
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407
Well-Life Healthcare Limited
Neurology
61d
Cleared
Mar 17, 2006
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406
Well-Life Healthcare Limited
Neurology
165d