K250758
- 510(k) number
- K250758
- Device name
- Electric Wheelchair (F309)
- Applicant
- Changshu Pingfang Wheelchair Co., Ltd. CN
- Product code
- ITI — Wheelchair, Powered
- Decision date
- 2025-05-09
- Date received
- 2025-03-13
- 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: K250758.pdf
Official FDA record: K250758
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.