INDEPENDENCE IBOT 3000/4000 MOBILITY SYSTEM
FDA premarket approval P020033/S002 · decided 2005-03-15
Approval details
- PMA number
- P020033
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INDEPENDENCE IBOT 3000/4000 MOBILITY SYSTEM
- Generic name
- Wheelchair, stair climbing
- Applicant
- Independence Technology, LLC
- Date received
- 2004-09-09
- Decision date
- 2005-03-15
- Days to decision
- 187 days
- Decision code
- APPR
- Product code
- IMK
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Somerville, NJ
- Statement
- APPROVAL FOR GENERATIONAL CHANGES TO THE APPROVED DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INDEPENDENCE IBOT 4000 MOBILITY SYSTEM. THE DEVICE IS INDICATED FOR INDIVIDUALS WHO HAVE MOBILITY IMPAIRMENTS AND THE USE OF AT LEAST ON UPPER EXTREMITY. THE DEVICE IS INTENDED 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 SE
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| IGLIDE MANUAL ASSIST WHEELCHAIR (K030250) | Independence Technology, LLC | 2003-03-04 |