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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device exerciser, measuring
Product CodeISD
Regulation Number 890.5360
Device Class 2


Premarket Reviews
ManufacturerDecision
LODE B.V.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2 2
2019 1 1
2021 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Corroded 1 1
Crack 1 1
Fracture 1 1
Use of Device Problem 1 1
Defective Component 1 1
Detachment of Device or Device Component 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 2 2
Limb Fracture 1 1
No Consequences Or Impact To Patient 1 1
Reaction 1 1
No Patient Involvement 1 1

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