K240012
- 510(k) number
- K240012
- Device name
- Mobility Scooter (W3431)
- Applicant
- Zhejiang Innuovo Rehabilitation Devices Co.,Ltd CN
- Product code
- INI — Vehicle, Motorized 3-Wheeled
- Decision date
- 2024-05-02
- Date received
- 2024-01-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240012.pdf
Official FDA record: K240012
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.