FDA 510(k) Application Details - K080385

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K080385
Device Name	Wheelchair, Powered
Applicant	E1 ENT., INC. 1290 S.W. 30TH AVE. POMPANO BEACH, FL 33069 US Other 510(k) Applications for this Company
Contact	JACK CHENG 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	02/13/2008
Decision Date	05/13/2008
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