K253285
- 510(k) number
- K253285
- Device name
- Elitone for Men
- Applicant
- Elidah, Inc. CT · US
- Product code
- QAJ — Cutaneous Electrode Stimulator For Urinary Incontine
- Decision date
- 2026-01-23
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253285.pdf
Official FDA record: K253285
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.