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 Well-Life Healthcare Limited, Everyway Medical Instruments Co.,Ltd and Andon Health Co, Ltd..
List of Stimulator, Nerve, Transcutaneous, Over-the-counter devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Stimulator, Nerve, Transcutaneous, Over-the-counter devices (product code NUH). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Neurology FDA review panel. Browse all Neurology devices →