Clearance Summary
Mobility Scooter (Model X-01, X-02) received FDA 510(k) clearance under submission number K242975, sponsored by Wuyi Aichi Industry & Trade Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2025-05-07.
- Submission: K242975
- Applicant / Sponsor: Wuyi Aichi Industry & Trade Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3800
- Decision date: 2025-05-07
Classification & Regulation
This clearance is catalogued under FDA product code INI and 21 CFR 890.3800, within the Physical Medicine review panel as a Class II device.