INDEPENDENCE (TM) IBOT 3000/4000 MOBILITY SYSTEM
FDA premarket approval P020033 · decided 2003-08-13
Approval details
- PMA number
- P020033
- Trade name
- INDEPENDENCE (TM) IBOT 3000/4000 MOBILITY SYSTEM
- Generic name
- Wheelchair, stair climbing
- Applicant
- Independence Technology, LLC
- Date received
- 2002-07-31
- Decision date
- 2003-08-13
- Days to decision
- 378 days
- Decision code
- APRL
- Product code
- IMK
- Advisory committee
- Physical Medicine
- Expedited review
- Yes
- Location
- Somerville, NJ
- 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 ELEV
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| IGLIDE MANUAL ASSIST WHEELCHAIR (K030250) | Independence Technology, LLC | 2003-03-04 |