BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AK Body Toning Device

    K Number: K152420 · Decision Dec 1, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    161
    Applicant Total
    1
    Review Days
    463

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    Basic Information

    Device Name
    AK Body Toning Device
    K Number
    K152420
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ak Beauty Enterprises, LLC
    Date Received
    August 26, 2015
    Decision Date
    December 1, 2016
    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

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