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 Changsha Anxiang Medical Technology Co., Ltd., Shenzhen Jiantuo Electronics Co., Ltd. and Well-Life Healthcare Limited.
FDA 510(k) Cleared Stimulator, Nerve, Transcutaneous, Over-the-counter Devices (Product Code NUH)
About Product Code NUH - Regulatory Context
510(k) Submission Activity
227 total 510(k) submissions under product code NUH since 2004, with 227 receiving FDA clearance (average review time: 180 days).
Submission volume has declined in recent years - 26 submissions in the last 24 months compared to 35 in the prior period.
FDA Review Time
Recent submissions under NUH have taken an average of 135 days to reach a decision - down from 186 days historically, suggesting improved FDA processing for this classification.
NUH devices are reviewed by the Neurology panel. Browse all Neurology devices →