FDA 510(k) Application Details - K971388

Device Classification Name	Vehicle, Motorized 3-Wheeled   More FDA Info for this Device
510(K) Number	K971388
Device Name	Vehicle, Motorized 3-Wheeled
Applicant	FREERIDER USA, INC. 2322 DOUGLAS DR. EUGENE, OR 97405 US Other 510(k) Applications for this Company
Contact	ROBERT S MCQUATE 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	04/14/1997
Decision Date	07/23/1997
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