PMA P020033S001

Device
INDEPENDENCE IBOT 3000 MOBILITY SYSTEM
Applicant
Independence Technology, LLC
PMA number
P020033
Supplement
S001
Product code
IMK
Decision date
2004-08-27
Classification
Physical Medicine
Generic name
Wheelchair, stair climbing
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.

Current openFDA PMA Record#

Device
INDEPENDENCE IBOT 3000 MOBILITY SYSTEM
Applicant
Independence Technology, LLC
PMA number
P020033
Supplement
S001
Product code
IMK
Generic name
Wheelchair, stair climbing
Decision date
2004-08-27
Decision code
APPR
Date received
2004-08-10
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
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.