FDA 510(k) Application Details - K160031

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K160031
Device Name	Wheelchair, Powered
Applicant	SUNRISE MEDICAL (US) LLC 2842 BUSINESS PARK AV FRESNO, CA 93727 US Other 510(k) Applications for this Company
Contact	LAURIE H ROBERTS 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	01/07/2016
Decision Date	07/14/2016
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