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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

MDR Year MDR Reports MDR Events
2021 2 2
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 3 3
Patient-Device Incompatibility 2 2
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 4 4
Failure of Implant 1 1
Deformity/ Disfigurement 1 1
Neck Pain 1 1
Neck Stiffness 1 1
Sleep Dysfunction 1 1
Tissue Breakdown 1 1
Unspecified Respiratory Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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