Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Theratech, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
232 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K060975 | IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & W | Theratech, Inc. | 2006-05-10 | 30 | 0 |
| K050847 | IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A | Theratech, Inc. | 2005-06-17 | 74 | 0 |
| K024100 | IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206 | Theratech, Inc. | 2003-02-25 | 75 | 0 |
| K021436 | TTECH MODEL 200E + TENS DEVICE | Theratech, Inc. | 2002-07-30 | 85 | 0 |
| K013768 | POWERED MUSCLE STIMULATOR | Theratech, Inc. | 2002-07-03 | 232 | 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