K243961
- 510(k) number
- K243961
- Device name
- Electrically Powered Wheelchair
- Applicant
- Kunshan Hi-Fortune Health Products Co., Ltd. CN
- Product code
- ITI — Wheelchair, Powered
- Decision date
- 2025-02-12
- Date received
- 2024-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243961.pdf
Official FDA record: K243961
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.