FDA 510(k) Application Details - K242327

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K242327
Device Name	Wheelchair, Powered
Applicant	Concourse Assistive Technology PTY LTD 9 Hamley Road Mount Kuring-Gai 2080 AU Other 510(k) Applications for this Company
Contact	David Mackay 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	08/06/2024
Decision Date	12/10/2024
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