510(k) K242975
K242975 is an FDA 510(k) premarket notification submitted by Wuyi Aichi Industry & Trade Co., Ltd. for the device "Mobility Scooter (Model X-01, X-02)". The FDA issued a decision of Substantially Equivalent on May 7, 2025. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Wuyi Aichi Industry & Trade Co., Ltd. has at least 1 other 510(k) clearance on record.
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