AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000)
Device Facts
| Record ID | K090966 |
|---|---|
| Device Name | AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000) |
| Applicant | Svrc Industries, Inc. |
| Product Code | INI · Physical Medicine |
| Decision Date | May 15, 2009 |
| Decision | SESE |
| Submission Type | Abbreviated |
| 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.
