Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Electro Therapeutic Devices, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
619 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981272 | ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES | Electro Therapeutic Devices, Inc. | 1998-08-24 | 139 | 0 |
| K875317 | ELECTRICAL MUSCLE STIMULATOR MODEL MYOAID | Electro Therapeutic Devices, Inc. | 1989-09-08 | 619 | 0 |
| K863567 | 'TENSAID' | Electro Therapeutic Devices, Inc. | 1986-10-24 | 42 | 0 |
| K863568 | 'MYOSTIM EX' | Electro Therapeutic Devices, Inc. | 1986-10-24 | 42 | 0 |
| K853719 | TRANSCUTANEOUS ELECT. NERVE STIMUL-MYOSTIM 410 | Electro Therapeutic Devices, Inc. | 1985-12-04 | 90 | 0 |
| K853718 | TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804 | Electro Therapeutic Devices, Inc. | 1985-12-04 | 90 | 0 |
| K843119 | ETI TENS BELT | Electro Therapeutic Devices, Inc. | 1984-08-17 | 9 | 0 |
| K770686 | THERATHERM | Electro Therapeutic Devices, Inc. | 1977-07-14 | 93 | 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