K014119 is an FDA 510(k) clearance for the WU'S 3-WHEELED NEO SCOOTER, WT-M3. 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 July 25, 2002, 220 days after receiving the submission on December 17, 2001.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K014119 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2001 |
| Decision Date | July 25, 2002 |
| Days to Decision | 220 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | INI — Vehicle, Motorized 3-wheeled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3800 |