Mobility Scooter (W3483, W3483A)
Device Facts
| Record ID | K260176 |
|---|---|
| Device Name | Mobility Scooter (W3483, W3483A) |
| Applicant | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd |
| Product Code | INI · Physical Medicine |
| Decision Date | Aug 10, 2026 |
| 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.
