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FDA 510(k) Application Details - K242430
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K242430
Device Name
Wheelchair, Powered
Applicant
Soul Mobility
659 River Bluff Circle
Oconomowoc, WI 53066 US
Other 510(k) Applications for this Company
Contact
Troy Tesmer
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
08/15/2024
Decision Date
11/12/2024
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 K242430
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