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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, sleep assessment
Product CodeLEL
Regulation Number 882.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
ACTIGRAPH, LLC
  SUBSTANTIALLY EQUIVALENT 1
ARBOR MEDICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
OXEHEALTH LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Electric Shock 1 1

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