510(k) K252590
K252590 is an FDA 510(k) premarket notification submitted by Intradin (Shanghai) Machinery Co., Ltd. for the device "Powered Mobility Scooter (PMS105, GUT177, GCAT047)". The FDA issued a decision of Substantially Equivalent on November 21, 2025. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Intradin (Shanghai) Machinery Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2025
- Date Received
- August 15, 2025
- 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