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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transport, patient, powered
Product CodeILK
Regulation Number 890.5150
Device Class 2


Premarket Reviews
ManufacturerDecision
STRYKER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 5 5
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult or Delayed Positioning 3 3
Difficult to Fold, Unfold or Collapse 2 2
Protective Measures Problem 2 2
No Apparent Adverse Event 1 1
Sharp Edges 1 1
Device Fell 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
Unspecified Musculoskeletal problem 1 1

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