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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.
 
Trade NameINDEPENDENCE IBOT 3000 MOBILITY SYSTEM
Classification Namewheelchair, stair climbing
Regulation Number890.3890
ApplicantINDEPENDENCE TECHNOLOGY, L.L.C.
PMA NumberP020033
Supplement NumberS001
Date Received08/18/2004
Decision Date08/27/2004
Product Code
IMK
Advisory Committee Physical Medicine
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the design of the wheel cluster housing access port cap/cover as well as labeling changes to the user manual that add a warning, a caution, and associated instructions regarding driving through debris.
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