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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
Regulation Description Stair-climbing wheelchair.
Definition A device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs. FDA interprets “mobility to persons restricted to a sitting position” to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility.
Product CodeIMK
Regulation Number 890.3890
Device Class 2


Premarket Reviews
ManufacturerDecision
MOBIUS MOBILITY
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 4 4
2022 3 3
2023 2 2
2024 2 2
2025 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 6 6
Off-Label Use 3 3
Device Tipped Over 2 2
Insufficient Information 2 2
Patient Device Interaction Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Device Slipped 1 1
Device Fell 1 1
Unintended Application Program Shut Down 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 6 6
Fall 6 6
Limb Fracture 5 5
Laceration(s) 4 4
Concussion 3 3
Multiple Fractures 2 2
Vertebral Fracture 2 2
Damage to Ligament(s) 1 1
Hip Fracture 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mobius Mobility LLC II Jun-12-2025
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