THE SPORTSTER (ELECTRIFIED WHEELCHAIR)
Device Facts
| Record ID | K853918 |
|---|---|
| Device Name | THE SPORTSTER (ELECTRIFIED WHEELCHAIR) |
| Applicant | Amigo Sales, Inc. |
| Product Code | INI · Physical Medicine |
| Decision Date | Jan 13, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| 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.