510(k) K222711
K222711 is an FDA 510(k) premarket notification submitted by Suzhou Master Machinery Manufacturing Co.,Ltd for the device "HS186B Scooter". The FDA issued a decision of Substantially Equivalent on January 9, 2023. 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
- January 9, 2023
- Date Received
- September 8, 2022
- 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