The following data is part of a premarket notification filed by Eurogreen International Inc. with the FDA for Supascoota Motorized Vehicle - Spartan (sumo)/ Spartan Sp (sumo Sp).
| Device ID | K182631 |
| 510k Number | K182631 |
| Device Name: | SupaScoota Motorized Vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP) |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | Eurogreen International Inc. No. 48, Lane 220, Sec. 1, Fu-Zun Rd., Yuan-Lin Township Chang-hua County, CN 51055 |
| Contact | David Hsieh |
| Correspondent | David Hsieh Eurogreen International Inc. No. 48, Lane 220, Sec. 1, Fu-Zun Rd., Yuan-Lin Township Chang-hua County, CN 51055 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-24 |
| Decision Date | 2019-09-19 |
| Summary: | summary |