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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cutaneous Electrode Stimulator For Urinary Incontinence
510(k) Number K253285
Device Name Elitone for Men
Applicant
Elidah, Inc.
31 Pecks Ln
Suite 11
Newtown,  CT  06470
Applicant Contact Gloria Kolb
Correspondent
Elidah, Inc.
31 Pecks Ln
Suite 11
Newtown,  CT  06470
Correspondent Contact Gloria Kolb
Regulation Number876.5330
Classification Product Code
QAJ  
Date Received09/29/2025
Decision Date 01/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT06620419
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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