FDA 510(k) Application Details - K063475

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K063475
Device Name	Wheelchair, Powered
Applicant	IMC-HEARTWAY, LLC 6140 MID METRO DRIVE, SUITE 6 FORT MYERS, FL 33912 US Other 510(k) Applications for this Company
Contact	MICHAEL CHEN 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	11/16/2006
Decision Date	01/23/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review