510(k) K252275
K252275 is an FDA 510(k) premarket notification submitted by Zhejiang Nysin Medical Co., Ltd. for the device "Electric Scooter (DDF100)". The FDA issued a decision of Substantially Equivalent on January 29, 2026. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Zhejiang Nysin Medical Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 2026
- Date Received
- July 22, 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