INDEPENDENCE IBOT 3000 MOBILITY SYSTEM
FDA premarket approval P020033/S001 · decided 2004-08-27
Approval details
- PMA number
- P020033
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INDEPENDENCE IBOT 3000 MOBILITY SYSTEM
- Generic name
- Wheelchair, stair climbing
- Applicant
- Independence Technology, LLC
- Date received
- 2004-08-10
- Decision date
- 2004-08-27
- Days to decision
- 17 days
- Decision code
- APPR
- Product code
- IMK
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Somerville, NJ
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| IGLIDE MANUAL ASSIST WHEELCHAIR (K030250) | Independence Technology, LLC | 2003-03-04 |