510(k) K240590

Electrical Scooter, WT-T4SU by W'U'S Tech Co., Ltd. — Product Code INI

K240590 is an FDA 510(k) premarket notification submitted by W'U'S Tech Co., Ltd. for the device "Electrical Scooter, WT-T4SU". The FDA issued a decision of Substantially Equivalent on Jan 8, 2025. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 8, 2025
Date Received
Mar 1, 2024
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