BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Miha Bodytec II

    K Number: K182519 · Decision Jun 7, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    152
    Applicant Total
    2
    Review Days
    267

    Basic Information

    Device Name
    Miha Bodytec II
    K Number
    K182519
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Miha Bodytec Gmbh
    Date Received
    September 13, 2018
    Decision Date
    June 7, 2019
    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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    Other Clearances by Miha Bodytec Gmbh

    K Number Device Name
    K201975 miha bodytec II