FDA 510(k) Application Details - K243111

Device Classification Name	Wheelchair, Mechanical   More FDA Info for this Device
510(K) Number	K243111
Device Name	Wheelchair, Mechanical
Applicant	Bowhead Design Corp. 6919 32 Ave NW Calgary T3B 0K6 CA Other 510(k) Applications for this Company
Contact	Tatiana Place 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	09/30/2024
Decision Date	01/10/2025
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