K244003
- 510(k) number
- K244003
- Device name
- Electrically powered wheelchair
- Applicant
- Kunshan Hi-Fortune Health Products Co., Ltd. CN
- Product code
- ITI — Wheelchair, Powered
- Decision date
- 2025-03-26
- Date received
- 2024-12-26
- 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: K244003.pdf
Official FDA record: K244003
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.