K252517
- 510(k) number
- K252517
- Device name
- Manual Wheelchair (SYIV100A008)
- Applicant
- Ningbo Shenyu Medical Equipment Co.,Ltd CN
- Product code
- IOR — Wheelchair, Mechanical
- Decision date
- 2025-10-03
- Date received
- 2025-08-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K252517
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.