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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 Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5890
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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