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

    Compex Sport Elite 3.0

    K Number: K201653 · Decision Nov 27, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    161
    Applicant Total
    12
    Review Days
    162

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    Basic Information

    Device Name
    Compex Sport Elite 3.0
    K Number
    K201653
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Djo, LLC
    Date Received
    June 18, 2020
    Decision Date
    November 27, 2020
    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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