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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namewheelchair, stair climbing
Generic Namewheelchair, stair climbing
Regulation Number890.3890
route 22 west
somerville, NJ 08876
PMA NumberP020033
Date Received07/31/2002
Decision Date08/13/2003
Withdrawal Date 10/01/2014
Product Code
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: S001 S002