510(k) K251638
K251638 is an FDA 510(k) premarket notification submitted by Suzhou Master Machinery Manufacturing Co.,Ltd for the device "Mobility Scooter (MS160C)". The FDA issued a decision of Substantially Equivalent on July 22, 2025. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Suzhou Master Machinery Manufacturing Co.,Ltd has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2025
- Date Received
- May 29, 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