K251565
- 510(k) number
- K251565
- Device name
- Wheelchair (N817)
- Applicant
- Zhejiang Topwe Tools Manufacturing Co.,Ltd CN
- Product code
- ITI — Wheelchair, Powered
- Decision date
- 2025-10-06
- Date received
- 2025-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K251565.pdf
Official FDA record: K251565
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.