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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
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 4
ELECTROCORE, LLC
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 3
ELETROCORE, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Swollen Lymph Nodes 1 1
Twitching 1 1
Numbness 1 1
Ambulation Difficulties 1 1

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