510(k) K250533

Magnesium alloy scooter (RS100) by Taizhou Reach Technology Co., Ltd. — Product Code INI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2025
Date Received
February 24, 2025
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