ROBO
Device Facts
| Record ID | K942508 |
|---|---|
| Device Name | ROBO |
| Applicant | Permobil AB |
| Product Code | INI · Physical Medicine |
| Decision Date | Nov 7, 1994 |
| Decision | SN |
| 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.