BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇪🇸 Spain

    Zionic Pro Max (EMS)

    K Number: K253636 · Decision Mar 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    161
    Applicant Total
    2
    Review Days
    113

    Basic Information

    Device Name
    Zionic Pro Max (EMS)
    K Number
    K253636
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Termosalud S.L.
    Date Received
    November 19, 2025
    Decision Date
    March 12, 2026
    Product Code
    NGX
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NGX Stimulator, Muscle, Powered, For Muscle Conditioning

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NGX), ordered by most recent decision date.

    Diacore

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CoolTone

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Motive™ Muscle Stimulator for Lower Back (OT01-1003)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    truFlex

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TENS and EMS Unit

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Termosalud S.L.

    K Number Device Name
    K243716 Zionic Pro Max (Radiofrequency)