FDA 510(k) Application Details - K042401

Device Classification Name	Wheelchair, Mechanical   More FDA Info for this Device
510(K) Number	K042401
Device Name	Wheelchair, Mechanical
Applicant	AMERICAN TRACK ROADSTERS, INC. 3535 SOUTH KIPLING STREET LAKEWOOD, CO 80235 US Other 510(k) Applications for this Company
Contact	GREG PEEK 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	09/03/2004
Decision Date	10/07/2004
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