OPTIMA
Device Facts
| Record ID | K011053 |
|---|---|
| Device Name | OPTIMA |
| Applicant | Medical Industries America, Inc. |
| Product Code | ITI · Physical Medicine |
| Decision Date | Apr 20, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3860 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
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.
