K033240 is an FDA 510(k) clearance for the BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200. This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Tung Keng Enterprise Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on December 18, 2003, 73 days after receiving the submission on October 6, 2003.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K033240 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 2003 |
| Decision Date | December 18, 2003 |
| Days to Decision | 73 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 |