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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINDEPENDENCE IBOT 3000/4000 MOBILITY SYSTEM
Generic NameWheelchair, stair climbing
Regulation Number890.3890
ApplicantIndependence Technology, LLC
Rte. 22 W.
Somerville, NJ 08876
PMA NumberP020033
Supplement NumberS002
Date Received09/09/2004
Decision Date03/15/2005
Reclassified Date04/14/2014
Product Code IMK 
Advisory Committee Physical Medicine
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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