FDA 510(k) Application Details - K191874

Device Classification Name	Wheelchair, Standup   More FDA Info for this Device
510(K) Number	K191874
Device Name	Wheelchair, Standup
Applicant	Permobil AB Box 120 S-861 23 Timra SE Other 510(k) Applications for this Company
Contact	Ivan Fernandez Other 510(k) Applications for this Contact
Regulation Number	890.3900   More FDA Info for this Regulation Number
Classification Product Code	IPL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2019
Decision Date	10/25/2019
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