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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
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 Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
Submission Type 510(k)
Regulation Number 882.5891
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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