K143557 is an FDA 510(k) clearance for the SupaScoota Motorized vehicle. This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Eurogreen International, Inc. (Changhua County, TW). The FDA issued a Cleared decision on September 16, 2015, 275 days after receiving the submission on December 15, 2014.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K143557 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2014 |
| Decision Date | September 16, 2015 |
| Days to Decision | 275 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 |