Submission Details
| 510(k) Number | K253936 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 09, 2025 |
| Decision Date | March 12, 2026 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
K253936 is an FDA 510(k) clearance for the Power Mobility Scooter (MJMA01, MJMA02), a Vehicle, Motorized 3-wheeled (Class II — Special Controls, product code INI), submitted by Nanjing Mijo Technology Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on March 12, 2026, 93 days after receiving the submission on December 9, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K253936 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 09, 2025 |
| Decision Date | March 12, 2026 |
| Days to Decision | 93 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 |