Power Wheelchair (OS-R-M01I)— 510(k) K260053
Substantially EquivalentBeijing OrionStar Technology Co., Ltd.
FDA 510(k) clearance K260053 for Power Wheelchair (OS-R-M01I), Substantially Equivalent on 2026-09-08. Applicant: Beijing OrionStar Technology Co., Ltd.. Device class: 2.
Summary
Beijing OrionStar Technology's Power Wheelchair, model OS-R-M01I, is filed under ITI, powered wheelchairs. The record gives no specifications beyond the model number.
Class II, 21 CFR 890.3860. Physical Medicine is both the classification panel and the review panel, and it came in as a Traditional 510(k).
OrionStar filed from Beijing, China. The decision came 243 calendar days after receipt (January 8 to September 8, 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.