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FDA 510(k) Application Details - K063474
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K063474
Device Name
Wheelchair, Powered
Applicant
IMC-HEARTWAY, LLC
6140 MID METRO DRIVE, SUITE 6
FORT MYERS, FL 33912 US
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Contact
MICHAEL CHEN
Other 510(k) Applications for this Contact
Regulation Number
890.3860
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Classification Product Code
ITI
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More FDA Info for this Product Code
Date Received
11/16/2006
Decision Date
12/22/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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