K243102 is an FDA 510(k) clearance for the Mobility Scooter (JT10). This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Jiangxi Jiangte Electric Vehicle Co., Ltd. (Yichun, CN). The FDA issued a Cleared decision on June 18, 2025, 261 days after receiving the submission on September 30, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K243102 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2024 |
| Decision Date | June 18, 2025 |
| Days to Decision | 261 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 |