K251638 is an FDA 510(k) clearance for the Mobility Scooter (MS160C). This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Suzhou Master Machinery Manufacturing Co.,Ltd (Kunshan, CN). The FDA issued a Cleared decision on July 22, 2025, 54 days after receiving the submission on May 29, 2025.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K251638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2025 |
| Decision Date | July 22, 2025 |
| Days to Decision | 54 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 |