510(k) K253285
K253285 is an FDA 510(k) premarket notification submitted by Elidah, Inc. for the device "Elitone for Men". The FDA issued a decision of Substantially Equivalent on Jan 23, 2026. The device falls under product code QAJ (Cutaneous Electrode Stimulator For Urinary Incontinence), a Class II device regulated under 21 CFR 876.5330. Elidah, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 23, 2026
- Date Received
- Sep 29, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cutaneous Electrode Stimulator For Urinary Incontinence
- Device Class
- Class II
- Regulation Number
- 876.5330
- Review Panel
- GU
- Submission Type
A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.