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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, nerve, transcutaneous, over-the-counter
Regulation Description Transcutaneous electrical nerve stimulator for pain relief.
Definition Temporary relief of pain due to sore/aching muscles.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeNUH
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurostimulation Devices Branch (NSDB)
Submission Type 510(k)
Regulation Number 882.5890
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible