K131302 is an FDA 510(k) clearance for the SOLAX. This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Dongguan Prestige Sporting Goods Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on November 26, 2013, 203 days after receiving the submission on May 7, 2013.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K131302 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2013 |
| Decision Date | November 26, 2013 |
| Days to Decision | 203 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 |