510(k) K253936
K253936 is an FDA 510(k) premarket notification submitted by Nanjing Mijo Technology Co., Ltd. for the device "Power Mobility Scooter (MJMA01, MJMA02)". The FDA issued a decision of Substantially Equivalent on March 12, 2026. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2026
- Date Received
- December 9, 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