K182631 is an FDA 510(k) clearance for the SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP). This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Eurogreen International, Inc. (Chang-Hua County, CN). The FDA issued a Cleared decision on September 19, 2019, 360 days after receiving the submission on September 24, 2018.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K182631 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2018 |
| Decision Date | September 19, 2019 |
| Days to Decision | 360 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 |