Submission Details
| 510(k) Number | K252835 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 05, 2025 |
| Decision Date | December 23, 2025 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
K252835 is an FDA 510(k) clearance for the Electric Scooter (S202572J, S2060, M2089, S2050), a Vehicle, Motorized 3-wheeled (Class II — Special Controls, product code INI), submitted by Guangdong Prestige Technology Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on December 23, 2025, 109 days after receiving the submission on September 5, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K252835 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 05, 2025 |
| Decision Date | December 23, 2025 |
| Days to Decision | 109 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 |