Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Electro-Med Health Industries, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
100 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K852077 | VERSA STIM 380, MUSCLE STIMULATOR | Electro-Med Health Industries, Inc. | 1985-08-21 | 100 | 0 |
| K832371 | EGS MODEL 300 | Electro-Med Health Industries, Inc. | 1983-10-06 | 80 | 0 |
| K832803 | STEAM PAK MOIST HEAT | Electro-Med Health Industries, Inc. | 1983-09-20 | 33 | 0 |
| K832804 | SESAM TABLE | Electro-Med Health Industries, Inc. | 1983-09-20 | 33 | 0 |
| K832370 | EGS MODEL 100-2 | Electro-Med Health Industries, Inc. | 1983-09-16 | 60 | 0 |
| K802107 | EGS #300 BATTERY OPER. PORTA. MUSCLE STI | Electro-Med Health Industries, Inc. | 1980-10-03 | 30 | 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