Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: INDEPENDENCE (TM) IBOT 3000/4000 MOBILITY SYSTEM
• Generic Name: Wheelchair, stair climbing
• Regulation Number: 890.3890
• Applicant: INDEPENDENCE TECHNOLOGY, L.L.C.; ROUTE 22 WEST; SOMERVILLE, NJ 08876
• PMA Number: P020033
• Date Received: 07/31/2002
• Decision Date: 08/13/2003
• Reclassified Date: 04/14/2014
• Product Code: IMK
• Docket Number: 03M-0375
• Advisory Committee: Physical Medicine
• Expedited Review Granted?: Yes
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order 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 ELEVATED HEIGHT; ASCENT AND DESCENT OF STAIRS WITH OR WITHOUT ASSISTANCE; AND MOBILITY AND TRANSPORTATION OF THE UNOCCUPIED PRODUCT.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S002 S001