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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodePCC
Regulation Number 882.5891
Device Class 2


Premarket Reviews
ManufacturerDecision
CEFALY TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 3
STX-MED SPRL
  GRANTED 1


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