510(k) K253643
K253643 is an FDA 510(k) premarket notification submitted by Shenzhen Zhimahuaerkai Technology Co., Ltd. for the device "Mobility Scooter (S3)". The FDA issued a decision of Substantially Equivalent on February 18, 2026. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Shenzhen Zhimahuaerkai Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 2026
- Date Received
- November 19, 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