FDA 510(k) Application Details - K200715

Device Classification Name	Wheelchair, Mechanical   More FDA Info for this Device
510(K) Number	K200715
Device Name	Wheelchair, Mechanical
Applicant	RoughRider America LLC 2233 California Street Berkley, CA 94703 US Other 510(k) Applications for this Company
Contact	Marc Krizack Other 510(k) Applications for this Contact
Regulation Number	890.3850   More FDA Info for this Regulation Number
Classification Product Code	IOR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2020
Decision Date	06/24/2022
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