510(k) K853918

THE SPORTSTER (ELECTRIFIED WHEELCHAIR) by Amigo Sales, Inc. — Product Code INI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1986
Date Received
September 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vehicle, Motorized 3-Wheeled
Device Class
Class II
Regulation Number
890.3800
Review Panel
PM
Submission Type