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510(k) K242975

Mobility Scooter (Model X-01, X-02) by Wuyi Aichi Industry & Trade Co., Ltd. — Product Code INI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2025
Date Received
September 26, 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

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