FDA PMA
FDA Class 2
Approved (Reclassification)
🇺🇸 United States
Wheelchair, Stair Climbing
PMA: P020033
·
Decision Aug 13, 2003
Classifications
1
FEI Numbers
2
Registration Numbers
2
Basic Information
- Device Name
- Wheelchair, Stair Climbing
- Trade Name
- INDEPENDENCE (TM) IBOT 3000/4000 MOBILITY SYSTEM
- PMA Number
- P020033
- Device Class
- FDA Class 2
- Product Code
- IMK
- Generic Name
- Wheelchair, stair climbing
- Regulation Number
- 890.3890
- Medical Specialty
- Physical Medicine
- Advisory Committee
- Physical Medicine
- Decision
- Approved (Reclassification)
- Decision Code
- APRL
- Decision Date
- August 13, 2003
- Date Received
- July 31, 2002
- Expedited Review
- Y
- Docket Number
- 03M-0375
Advisory Committee Statement
APPROVAL FOR THE INDEPENDENCE IBOT 3000 MOBILITY SYSTEM. THE DEVICE IS INDICATED FOR INDIVIDUALS WHO HAVE MOBILITY IMPAIRMENTS AND THE USE OF AT LEAST ONE UPPER EXTREMITY. THE DEVICE IS INTENDED TO PROVIDE UP TO FIVE OPERATING FUNCTIONS. THE PURPOSES OF THESE FUNCTIONS ARE TO PROVIDE MOBILITY ON SMOOTH SURFACES AND INCLINES AT HOME, AT WORK AND IN OTHER ENVIRONMENTS; MOVEMENT ACROSS OBSTACLES, UNEVEN TERRAIN, CURBS, GRASS, GRAVEL, AND OTHER SOFT SURFACES; MOBILITY IN A SEATED POSITION AT AN ELEVATED HEIGHT; ASCENT AND DESCENT OF STAIRS WITH OR WITHOUT ASSISTANCE; AND MOBILITY AND TRANSPORTATION OF THE UNOCCUPIED PRODUCT.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IMK | Wheelchair, Stair Climbing | FDA class 2 | Physical Medicine |