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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
Regulation Description Powered patient transport.
Product CodeILK
Regulation Number 890.5150
Device Class 2


Premarket Reviews
ManufacturerDecision
CLIMBING STEPS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 5 5
2024 18 20
2025 32 51

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult or Delayed Positioning 18 27
Protective Measures Problem 15 20
Sharp Edges 7 7
Difficult to Fold, Unfold or Collapse 6 9
Unintended System Motion 6 10
Device Fell 5 5
Device Tipped Over 2 2
Adverse Event Without Identified Device or Use Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 51 69
Pain 3 9
Insufficient Information 2 5
Electric Shock 1 1
Unspecified Musculoskeletal problem 1 1
Abrasion 1 4
Bruise/Contusion 1 4

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