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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning
510(k) Number K253636
Device Name Zionic Pro Max (EMS)
Applicant
Termosalud S.L.
Ataulfo Friera Tarfe 8
Gijon,  ES 33211
Applicant Contact Cristina Cifuentes
Correspondent
Hoy & Associates Regulatory Consulting, LLC
1830 Bonnie Way
Sacramento,  CA  95825
Correspondent Contact Connie Hoy
Regulation Number890.5850
Classification Product Code
NGX  
Date Received11/19/2025
Decision Date 03/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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