PMA P020033S002

Device: INDEPENDENCE IBOT 3000/4000 MOBILITY SYSTEM
Applicant: Independence Technology, LLC
PMA number: P020033
Supplement: S002
Product code: IMK
Decision date: 2005-03-15
Classification: Physical Medicine
Generic name: Wheelchair, stair climbing
Approval order 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 SEATED POSITION AT AN ELEVATED HEIGHT; ASCENT AND DECENT OF STAIRS WITH OR WITHOUT ASSISTANCE; AND MOBILITY AND TRANSPORTATION.

Current openFDA PMA Record#

Device: INDEPENDENCE IBOT 3000/4000 MOBILITY SYSTEM
Applicant: Independence Technology, LLC
PMA number: P020033
Supplement: S002
Product code: IMK
Generic name: Wheelchair, stair climbing
Decision date: 2005-03-15
Decision code: APPR
Date received: 2004-09-09
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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 SEATED POSITION AT AN ELEVATED HEIGHT; ASCENT AND DECENT OF STAIRS WITH OR WITHOUT ASSISTANCE; AND MOBILITY AND TRANSPORTATION.