FDA 510(k) Application Details - K012592

Device Classification Name	Vehicle, Motorized 3-Wheeled   More FDA Info for this Device
510(K) Number	K012592
Device Name	Vehicle, Motorized 3-Wheeled
Applicant	TZORA ACTIVE SYSTEMS LTD. KIBBUTZ TZORA 99803 IL Other 510(k) Applications for this Company
Contact	YOEL ETZIONI Other 510(k) Applications for this Contact
Regulation Number	890.3800   More FDA Info for this Regulation Number
Classification Product Code	INI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/10/2001
Decision Date	10/03/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review