510(k) clearance
Power Wheelchair (OS-R-M01I)
- 510(k) number
- K260053
- Applicant
- Beijing OrionStar Technology Co., Ltd.
- Decision date
- Sep 8, 2026
- Date received
- Jan 8, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- ITI
- Device type
- Wheelchair, Powered
- Device class
- Class II
- Regulation
- 21 CFR 890.3860
- Advisory committee
- Physical Medicine
- Statement or summary
- Statement
- Third party
- N
- Location
- Beijing, CN