K253643
- 510(k) number
- K253643
- Device name
- Mobility Scooter (S3)
- Applicant
- Shenzhen Zhimahuaerkai Technology Co., Ltd. CN
- Product code
- INI — Vehicle, Motorized 3-Wheeled
- Decision date
- 2026-02-18
- Date received
- 2025-11-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K253643
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.