K253952
- 510(k) number
- K253952
- Device name
- Power Wheelchair (OS-R-M01S)
- Applicant
- Beijing OrionStar Technology Co., Ltd. CN
- Product code
- ITI — Wheelchair, Powered
- Decision date
- 2026-04-07
- Date received
- 2025-12-10
- 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: K253952
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.