DURABLE MEDICAL EQUIPMENT COMPANY, STANDARD MECHANICAL WHEELCHAIR
Device Facts
| Record ID | K934297 |
|---|---|
| Device Name | DURABLE MEDICAL EQUIPMENT COMPANY, STANDARD MECHANICAL WHEELCHAIR |
| Applicant | Durable Medical Equipment, Inc. |
| Product Code | IOR · Physical Medicine |
| Decision Date | Nov 1, 1993 |
| 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.