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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Non-Implantable, For Incontinence
510(k) Number K243079
Device Name NeuroTrac® MyoPlus Pro (MYO120U)
Applicant
Verity Medical , Ltd.
Churchtown House
Tagoat,  IE Y35 XY44
Applicant Contact Nigel Verity
Correspondent
Verity Medical , Ltd.
Churchtown House
Tagoat,  IE Y35 XY44
Correspondent Contact Nigel Verity
Regulation Number876.5320
Classification Product Code
KPI  
Subsequent Product Code
HCC  
Date Received09/30/2024
Decision Date 06/26/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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