K192308 is an FDA 510(k) clearance for the Wu's Electrical Scooter. This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Wu'S Tech Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on December 21, 2020, 483 days after receiving the submission on August 26, 2019.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K192308 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2019 |
| Decision Date | December 21, 2020 |
| Days to Decision | 483 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 |