510(k) K955276

BOOSTER LITE 4 MOTORIZED SCOOTER by Optimed Technologies, Inc. — Product Code INI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1996
Date Received
November 15, 1995
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