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510(k) Data Aggregation

    K Number
    K253636

    Validate with FDA (Live)

    Device Name
    Zionic Pro Max (EMS)
    Manufacturer
    Termosalud S.L.
    Date Cleared
    2026-03-12

    (113 days)

    Product Code
    NGX
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Zionic Pro Max EMS function of the device is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the muscles by the Zionic Pro Max programs is not suitable for rehabilitation or physiotherapy.

    Device Description

    The ZIONIC Pro Max is an innovative electrical impulse generator that generates electrical muscle stimulation (EMS) energy to subcutaneous tissue by way of contact with intact skin. The device includes and console and user interface that power a selection of handpieces that deliver EMS to intact skin. The device is intended for use by medical professionals.

    AI/ML Overview

    N/A

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