MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651
Device Facts
| Record ID | K001252 |
|---|---|
| Device Name | MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651 |
| Applicant | Maxhealth Corp. |
| Product Code | IOR · Physical Medicine |
| Decision Date | Jun 12, 2000 |
| 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.
