K250027
- 510(k) number
- K250027
- Device name
- Powered Mobility Scooter
- Applicant
- Intradin (Shanghai) Machinery Co., Ltd. CN
- Product code
- INI — Vehicle, Motorized 3-Wheeled
- Decision date
- 2025-02-21
- Date received
- 2025-01-06
- Decision
- Substantially Equivalent
- Clearance type
- Special
- 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: K250027
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.