Submission Details
| 510(k) Number | K253631 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 19, 2025 |
| Decision Date | February 23, 2026 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
K253631 is an FDA 510(k) clearance for the Mobility Scooter (CL-Q3, CL-Q4), a Vehicle, Motorized 3-wheeled (Class II — Special Controls, product code INI), submitted by Zhejiang Wei Ling New Energy Technology Co., Ltd. (Taizhou, CN). The FDA issued a Cleared decision on February 23, 2026, 96 days after receiving the submission on November 19, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K253631 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 19, 2025 |
| Decision Date | February 23, 2026 |
| Days to Decision | 96 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 |