Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tone-A-Matic International, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222863 | Garment Electrodes | Tone-A-Matic International, Inc. | 2023-02-01 | 132 | 0 |
| K221724 | Conductive Gel | Tone-A-Matic International, Inc. | 2022-09-23 | 101 | 0 |
| K143059 | TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator) | Tone-A-Matic International, Inc. | 2015-01-26 | 94 | 0 |
| K130052 | TONE-A-MATIC | Tone-A-Matic International, Inc. | 2013-12-20 | 345 | 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