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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mouthguard, migraine/tension headache
Definition A device to be used in the prophylactic treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches, by reducing their signs and symptoms through reduction of trigeminally innervated muscular activity, and; For the prevention of bruxism and tmj syndrome through reduction of trigeminally innervated muscular activity.
Product CodeOCO
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
MOONWALKER INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1

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