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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device table, physical therapy, multi function
Product CodeJFB
Regulation Number 890.5880
Device Class 2


Premarket Reviews
ManufacturerDecision
CERAGEM CO, LTD.
  SUBSTANTIALLY EQUIVALENT 3
NUGA MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2022 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 3 3
Break 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Laceration(s) 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Head Injury 1 1
Bruise/Contusion 1 1

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