Manual Wheelchair (MS01);Manual Wheelchair (MA01)
Device Facts
| Record ID | K261075 |
|---|---|
| Device Name | Manual Wheelchair (MS01);Manual Wheelchair (MA01) |
| Applicant | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. |
| Product Code | IOR · Physical Medicine |
| Decision Date | Jun 22, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3850 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.
