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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 K251026
Device Name Regenesis EMS Chair
Applicant
Trinity Medical Solutions
105 Citation Ct.
Birmingham,  AL  35209
Applicant Contact Mark Rohrer
Correspondent
Hoy and Associates Regulatory Consulting
1830 Bonnie Way
Sacramento,  CA  95825
Correspondent Contact Jamie Owsiany
Regulation Number876.5320
Classification Product Code
KPI  
Date Received04/02/2025
Decision Date 08/29/2025
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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