K192885 is an FDA 510(k) clearance for the C.T.M. Mobility Scooter HS-268. This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Chien TI Enterprise Co., Ltd. (New Taipei City, Hsin Chuang District, TW). The FDA issued a Cleared decision on December 9, 2019, 60 days after receiving the submission on October 10, 2019.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K192885 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 2019 |
| Decision Date | December 09, 2019 |
| Days to Decision | 60 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 |