FDA 510(k) Application Details - K161425

Device Classification Name	Wheelchair, Mechanical   More FDA Info for this Device
510(K) Number	K161425
Device Name	Wheelchair, Mechanical
Applicant	Motion Composites 519 J. Oswald Forest-suite 101 St-Roch-de-l'Achigan J0K3H0 CA Other 510(k) Applications for this Company
Contact	Stephane Le Beau 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	05/23/2016
Decision Date	12/05/2016
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