FDA 510(k) Application Details - K231315

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K231315
Device Name	Wheelchair, Powered
Applicant	Velox Manufacturing Inc Unit 15 26157 Fraser Hwy Langley V4W2W8 CA Other 510(k) Applications for this Company
Contact	Ryan Batke 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	05/05/2023
Decision Date	01/12/2024
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