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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wheelchair, stair climbing
Definition PMA To Be Filed by 7/12/00 (65 FR 19834 (4/13/00))
Product CodeIMK
Regulation Number 890.3890
Device Class 2


Premarket Reviews
ManufacturerDecision
MOBIUS MOBILITY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 4 4
2022 3 3
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 2 2
Off-Label Use 2 2
Device Tipped Over 2 2
Device Fell 1 1
Improper or Incorrect Procedure or Method 1 1
Insufficient Information 1 1
Device Slipped 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 5 5
Bone Fracture(s) 2 2
Laceration(s) 2 2
Limb Fracture 2 2
Unspecified Tissue Injury 1 1
Concussion 1 1
Hip Fracture 1 1

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