K261571
- 510(k) number
- K261571
- Device name
- Manual Wheelchair (H008, PCK7)
- Applicant
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. CN
- Product code
- IOR — Wheelchair, Mechanical
- Decision date
- 2026-08-06
- Date received
- 2026-05-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K261571.pdf
Official FDA record: K261571
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.