Power Wheelchair (OS-R-M01S)— 510(k) K253952
Substantially EquivalentBeijing OrionStar Technology Co., Ltd.
FDA 510(k) clearance K253952 for Power Wheelchair (OS-R-M01S), Substantially Equivalent on 2026-04-07. Applicant: Beijing OrionStar Technology Co., Ltd.. Device class: 2.
Summary
Beijing OrionStar Technology's Power Wheelchair (model OS-R-M01S) is filed under product code ITI (Wheelchair, Powered).
Class II, 21 CFR 890.3860. Physical Medicine is both the classification panel and the review panel. It came in as a Traditional 510(k).
Beijing OrionStar Technology filed from Beijing, China. The record shows 118 calendar days from receipt to decision (December 10, 2025 to April 7, 2026).
Clearance details
- Applicant
- Beijing OrionStar Technology Co., Ltd.
- Product code
- Product code ITI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3860
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beijing, CN
Recent devices under product code ITI
view allMore clearances from Beijing OrionStar Technology Co., Ltd.
view allAdverse events under product code ITI
product code ITI- Death
- 34
- Injury
- 778
- Malfunction
- 1,085
- Other
- 1
- Total
- 1,898
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.