K252590
- 510(k) number
- K252590
- Device name
- Powered Mobility Scooter (PMS105, GUT177, GCAT047)
- Applicant
- Intradin (Shanghai) Machinery Co., Ltd. CN
- Product code
- INI — Vehicle, Motorized 3-Wheeled
- Decision date
- 2025-11-21
- Date received
- 2025-08-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252590.pdf
Official FDA record: K252590
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.