Power Wheelchair (OS-R-M01S)
Device Facts
| Record ID | K253952 |
|---|---|
| Device Name | Power Wheelchair (OS-R-M01S) |
| Applicant | Beijing OrionStar Technology Co., Ltd. |
| Product Code | ITI · Physical Medicine |
| Decision Date | Apr 7, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3860 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.
