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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device non-invasive vagus nerve stimulator - headache
Regulation Description External vagal nerve stimulator for headache.
Definition The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat cluster headache and to reduce the frequency of cluster headache attacks.
Product CodePKR
Regulation Number 882.5892
Device Class 2


Premarket Reviews
ManufacturerDecision
ELECTROCORE, INC.
  SUBSTANTIALLY EQUIVALENT 3

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