MODIFICATION TO SOLO
Device Facts
| Record ID | K011107 |
|---|---|
| Device Name | MODIFICATION TO SOLO |
| Applicant | Ranger All Season Corp. |
| Product Code | INI · Physical Medicine |
| Decision Date | May 14, 2001 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 890.3800 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.