510(k) K013788

TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5 by Merits Health Products Co., Ltd. — Product Code INI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2001
Date Received
November 14, 2001
Clearance Type
Special
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