Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Healthonics, Inc. · 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) |
|---|---|---|---|---|---|
| K060669 | MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, S | Healthonics, Inc. | 2006-10-13 | 213 | 0 |
| K030998 | MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-300 | Healthonics, Inc. | 2003-10-10 | 193 | 0 |
| K003507 | MEDRELIEF | Healthonics, Inc. | 2001-02-21 | 100 | 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