510(k) K231472
K231472 is an FDA 510(k) premarket notification submitted by Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. for the device "Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)". The FDA issued a decision of Substantially Equivalent on July 19, 2023. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 2023
- Date Received
- May 22, 2023
- 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