Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Chien TI Enterprise Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192885 | C.T.M. Mobility Scooter HS-268 | Chien TI Enterprise Co., Ltd. | 2019-12-09 | 60 | 0 |
| K181344 | C.T.M Mobility Scooter | Chien TI Enterprise Co., Ltd. | 2018-12-14 | 207 | 0 |
| K162952 | C.T.M. Mobility Scooter | Chien TI Enterprise Co., Ltd. | 2017-05-03 | 191 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda