Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Physio Technology, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
192 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K883893 | OMNISOUND(TM) 3000 | Physio Technology, Inc. | 1988-11-01 | 48 | 0 |
| K874076 | MODIFIED OMNISTIM(TM) ELECTRICAL MUSCLE STIMULATOR | Physio Technology, Inc. | 1988-01-04 | 90 | 0 |
| K861039 | OMNIVAC (VACUUM ELECTRODE SYSTEM) | Physio Technology, Inc. | 1986-09-26 | 192 | 0 |
| K850850 | AUTOMOVE/OMNISTIM IV-ELECTRICAL MUSCLE STIMULATOR | Physio Technology, Inc. | 1985-07-01 | 122 | 0 |
| K850851 | G5 APPARATUS T, K1, K3 & THE PRESIDENT MODEL'S | Physio Technology, Inc. | 1985-06-25 | 116 | 0 |
| K850849 | MYOMETER EMG BIOFEEDBACK DEVICE | Physio Technology, Inc. | 1985-05-31 | 91 | 0 |
| K843372 | OMNISOUND THERAPY UNIT | Physio Technology, Inc. | 1984-09-18 | 21 | 0 |
| K843351 | OMNISTIM II COMBIN. THERAPY SYS | Physio Technology, Inc. | 1984-09-18 | 22 | 0 |
| K841874 | MEGA PULSE THERAPY UNIT | Physio Technology, Inc. | 1984-05-31 | 24 | 0 |
| K841278 | OMNISTIM III INTERFERENTIAL THERAPY | Physio Technology, Inc. | 1984-04-24 | 27 | 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