FDA 510(k) Application Details - K193599

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K193599
Device Name	Wheelchair, Powered
Applicant	21st Century Scientific, Inc. 4931 N Manufacturing Way Coeur d'Alene, ID 83815 US Other 510(k) Applications for this Company
Contact	RD Davidson 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	12/23/2019
Decision Date	09/03/2020
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