Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Electromedical Products, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
672 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K903014 | ALPHA-STIM CS | Electromedical Products, Inc. | 1992-05-12 | 672 | 0 |
| K896948 | ALPHA-STIM CS | Electromedical Products, Inc. | 1990-02-23 | 72 | 0 |
| K881753 | ALPHA-STIM 350 | Electromedical Products, Inc. | 1988-08-30 | 131 | 0 |
| K831145 | ALPHA-STIM 350 | Electromedical Products, Inc. | 1983-07-07 | 90 | 0 |
| K831144 | ALPHA-STIM 2000 | Electromedical Products, Inc. | 1983-06-30 | 83 | 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