510(k) K260237

Mobility Scooter (X-12, X-14, X-17) by Wuyi Aichi Industry and Trade Co., Ltd. — Product Code INI

K260237 is an FDA 510(k) premarket notification submitted by Wuyi Aichi Industry and Trade Co., Ltd. for the device "Mobility Scooter (X-12, X-14, X-17)". The FDA issued a decision of Substantially Equivalent on April 22, 2026. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Wuyi Aichi Industry and Trade Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2026
Date Received
January 26, 2026
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