Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Well-Life Healthcare, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
361 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040512 | LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203 | Well-Life Healthcare, Inc. | 2004-05-27 | 90 | 0 |
| K033857 | T-TECH DIGITAL, MODEL WL-22XXA SERIES | Well-Life Healthcare, Inc. | 2003-12-19 | 8 | 0 |
| K030537 | DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B | Well-Life Healthcare, Inc. | 2003-03-20 | 28 | 0 |
| K020020 | THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS- | Well-Life Healthcare, Inc. | 2002-12-30 | 361 | 0 |
| K020314 | DIGI-PRO TENS, MODEL WL-2204 AND WL-2205 | Well-Life Healthcare, Inc. | 2002-04-30 | 90 | 0 |
| K021359 | DIGI-PRO TENS MODEL WL-2203 AND WL-2205 | Well-Life Healthcare, Inc. | 2002-04-30 | 90 | 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