Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Electronic Waveform Laboratory, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
221 daysmedian FDA review time
379 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103738 | H-WAVE | Electronic Waveform Laboratory, Inc. | 2011-06-01 | 161 | 0 |
| K081998 | H-WAVE SPORT | Electronic Waveform Laboratory, Inc. | 2009-07-09 | 360 | 0 |
| K915230 | H WAVE MUSCLE STIMULATOR | Electronic Waveform Laboratory, Inc. | 1992-05-08 | 170 | 0 |
| K873604 | E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY | Electronic Waveform Laboratory, Inc. | 1988-04-12 | 221 | 0 |
| K862121 | E.W.L. P-TENS/H-WAVE | Electronic Waveform Laboratory, Inc. | 1987-06-17 | 379 | 0 |
| K813601 | E.W.L. P-TENS MODEL(TENS | Electronic Waveform Laboratory, Inc. | 1982-03-19 | 81 | 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