FDA PMA
FDA Class 2
Approved
🇺🇸 United States
Wheelchair, Stair Climbing
PMA: P020033
·
Supplement: S001
·
Decision Aug 27, 2004
Classifications
1
FEI Numbers
2
Registration Numbers
2
Basic Information
- Device Name
- Wheelchair, Stair Climbing
- Trade Name
- INDEPENDENCE IBOT 3000 MOBILITY SYSTEM
- PMA Number
- P020033
- Supplement Number
- S001
- 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
- Decision Code
- APPR
- Decision Date
- August 27, 2004
- Date Received
- August 10, 2004
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A CHANGE TO THE DESIGN OF THE WHEEL CLUSTER HOUSING ACCESS PORT CAP/COVER AS WELL AS LABELING CHANGES TO THE USER MANUAL THAT ADD A WARNING, A CAUTION, AND ASSOCIATED INSTRUCTIONS REGARDING DRIVING THROUGH DEBRIS.
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 |