K252813 is an FDA 510(k) clearance for the Electrical Scooter (SM4226). This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. (Zhongshan, CN). The FDA issued a Cleared decision on March 17, 2026, 194 days after receiving the submission on September 4, 2025.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K252813 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2025 |
| Decision Date | March 17, 2026 |
| Days to Decision | 194 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 |