Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Universal Technology Systems, 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) |
|---|---|---|---|---|---|
| K980346 | ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000) | Universal Technology Systems, Inc. | 1998-04-28 | 90 | 0 |
| K905107 | UTS ELECTRICAL MUSCLE STIMULATION DEVICE-PGS 1500 | Universal Technology Systems, Inc. | 1991-08-19 | 279 | 0 |
| K895760 | ELECTRICAL MUSCLE STIMULATOR--PGS 2000 TENS DEVICE | Universal Technology Systems, Inc. | 1990-01-02 | 98 | 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