K252687
- 510(k) number
- K252687
- Device name
- Manual Wheelchair (HM305-Air1, HM305-Air2)
- Applicant
- Suzhou Master Machinery Manufacturing Co.,Ltd CN
- Product code
- IOR — Wheelchair, Mechanical
- Decision date
- 2025-11-21
- Date received
- 2025-08-26
- 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: K252687
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.