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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, transcutaneous electrical, aesthetic purposes
Regulation Description Transcutaneous electrical nerve stimulator for pain relief.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeNFO
Premarket Review Office of 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
Accredited Persons
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