K190737 is an FDA 510(k) clearance for the Solax Electric Scooter (Models: S204311M, S204161, S204143). 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 May 10, 2021, 780 days after receiving the submission on March 22, 2019.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K190737 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 2019 |
| Decision Date | May 10, 2021 |
| Days to Decision | 780 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | INI - Vehicle, Motorized 3-wheeled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3800 |