K250027 is an FDA 510(k) clearance for the Powered Mobility Scooter. This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Intradin (Shanghai) Machinery Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on February 21, 2025, 46 days after receiving the submission on January 6, 2025.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K250027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 2025 |
| Decision Date | February 21, 2025 |
| Days to Decision | 46 days |
| Submission Type | Special |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | INI - Vehicle, Motorized 3-wheeled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3800 |