K202549 is an FDA 510(k) clearance for the Solax Electric Scooter (Model: S202261B). This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Dongguan Prestige Sporting Goods Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on February 26, 2021, 176 days after receiving the submission on September 3, 2020.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K202549 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2020 |
| Decision Date | February 26, 2021 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| 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 |