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FDA 510(k) Application Details - K221215
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K221215
Device Name
Wheelchair, Powered
Applicant
Alber GmbH
Vor dem Wei▀en Stein 14
Albstadt-Tailfingen 72461 DE
Other 510(k) Applications for this Company
Contact
Christoph Hauschel
Other 510(k) Applications for this Contact
Regulation Number
890.3860
More FDA Info for this Regulation Number
Classification Product Code
ITI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/27/2022
Decision Date
05/24/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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