K091212 is an FDA 510(k) clearance for the WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H. 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 May 27, 2009, 30 days after receiving the submission on April 27, 2009.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K091212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2009 |
| Decision Date | May 27, 2009 |
| Days to Decision | 30 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 |