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FDA 510(k) Application Details - K240105
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K240105
Device Name
Wheelchair, Powered
Applicant
Forcemech International LLC
4111 Rice Drier Road #1H
Pearland, TX 77581 US
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Contact
David Ou
Other 510(k) Applications for this Contact
Regulation Number
890.3860
More FDA Info for this Regulation Number
Classification Product Code
ITI
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More FDA Info for this Product Code
Date Received
01/16/2024
Decision Date
08/29/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K240105
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