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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 3 5

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult or Delayed Positioning 11 13
Protective Measures Problem 7 9
Sharp Edges 4 4
Difficult to Fold, Unfold or Collapse 3 3
Device Fell 2 2
Adverse Event Without Identified Device or Use Problem 1 1
No Apparent Adverse Event 1 1
Unintended System Motion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23 27
Electric Shock 1 1
Unspecified Musculoskeletal problem 1 1
Insufficient Information 1 1
Pain 1 1

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