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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, nerve, electrical, transcutaneous, for migraine
Regulation Description Transcutaneous electrical nerve stimulator to treat headache.
Definition Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.
Physical State Electrical stimulation unit with leads and cutaneous electrodes.
Technical Method Applies an electrical current through electrodes on patient's skin.
Target Area Afferent cranial nerves.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodePCC
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5891
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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