FDA 510(k) Application Details - K191376

Device Classification Name	Wheelchair, Standup   More FDA Info for this Device
510(K) Number	K191376
Device Name	Wheelchair, Standup
Applicant	Motion Concepts 84 Citation Drive, Unit #1 Concord L4K 3C1 CA Other 510(k) Applications for this Company
Contact	Dona Bhamra 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	05/23/2019
Decision Date	08/13/2019
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