The following data is part of a premarket notification filed by Chien Ti Enterprise Co., Ltd. with the FDA for C.t.m. Mobility Scooter Hs-268.
| Device ID | K192885 |
| 510k Number | K192885 |
| Device Name: | C.T.M. Mobility Scooter HS-268 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | Chien Ti Enterprise Co., Ltd. No. 13, Lane 227, Fu Ying Rd New Taipei City, Hsin Chuang District, TW 24258 |
| Contact | Vivian Lo |
| Correspondent | Vivian Lo Chien Ti Enterprise Co., Ltd. No. 13, Lane 227, Fu Ying Rd New Taipei City, Hsin Chuang District, TW 24258 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-10 |
| Decision Date | 2019-12-09 |