K253285 is an FDA 510(k) clearance for the Elitone for Men. This device is classified as a Cutaneous Electrode Stimulator For Urinary Incontinence (Class II - Special Controls, product code QAJ).
Submitted by Elidah, Inc. (Newtown, US). The FDA issued a Cleared decision on January 23, 2026, 116 days after receiving the submission on September 29, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5330. A Transcutaneous Electrical Continence Device Consists Of Cutaneous Electrodes That Are Used To Apply External Stimulation To Reduce Urinary Incontinence..
| 510(k) Number | K253285 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2025 |
| Decision Date | January 23, 2026 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | QAJ - Cutaneous Electrode Stimulator For Urinary Incontinence |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5330 |
| Definition | A Transcutaneous Electrical Continence Device Consists Of Cutaneous Electrodes That Are Used To Apply External Stimulation To Reduce Urinary Incontinence. |