510(k) K063032

COMFORT SCOOTER, MODEL LY-EW415 by Comfort Orthopedic Co., Ltd. — Product Code INI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2006
Date Received
October 3, 2006
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