FDA 510(k) Application Details - K192618

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K192618
Device Name	Wheelchair, Powered
Applicant	Alber GmbH Vor dem Weissen Stein 21 Albstadt 72461 DE Other 510(k) Applications for this Company
Contact	Michael Vent 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	09/23/2019
Decision Date	11/02/2020
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