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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 MOBILITY SYSTEM
Generic NameWheelchair, stair climbing
Regulation Number890.3890
ApplicantIndependence Technology, LLC
Rte. 22 W.
Somerville, NJ 08876
PMA NumberP020033
Supplement NumberS001
Date Received08/10/2004
Decision Date08/27/2004
Reclassified Date04/14/2014
Product Code IMK 
Advisory Committee Physical Medicine
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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