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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namewheelchair, stair climbing
Generic Namestair climibing wheelchair
Regulation Number890.3890
PMA NumberP020033
Supplement NumberS002
Date Received09/17/2004
Decision Date03/15/2005
Product Code
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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.