K251159
- 510(k) number
- K251159
- Device name
- Power wheelchair
- Applicant
- Zhenjiang Assure Medical Equipment Co., Ltd. CN
- Product code
- ITI — Wheelchair, Powered
- Decision date
- 2025-12-22
- Date received
- 2025-04-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251159.pdf
Official FDA record: K251159
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.