Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Remed 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) |
|---|---|---|---|---|---|
| K220625 | ALTMS Magnetic Stimulation Therapy System, Blossom TMS Thera | Remed Co., Ltd. | 2022-04-06 | 34 | 0 |
| K202537 | ALTMS Magnetic Stimulation Therapy System | Remed Co., Ltd. | 2021-11-26 | 451 | 0 |
| K202031 | Talent-Pro Electromagnetic Stimulator | Remed Co., Ltd. | 2021-05-06 | 288 | 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