510(k) K253285 ยท QAJ Cutaneous Electrode Stimulator For Urinary Incontinence
Elitone for Men
| Applicant | Elidah, Inc., Newtown CT, US |
| Decision | Substantially Equivalent, Jan 23, 2026 |
| Received | Sep 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253285
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.