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

    ACTIVATOR V-E

    K Number: K112606 · Decision Mar 6, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    31
    Applicant Total
    3
    Review Days
    180

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    Basic Information

    Device Name
    ACTIVATOR V-E
    K Number
    K112606
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Activator Methods International, Ltd.
    Date Received
    September 8, 2011
    Decision Date
    March 6, 2012
    Product Code
    LXM
    Advisory Committee
    Unknown
    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
    LXM Manipulator, Plunger-Like Joint

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    Other Clearances by Activator Methods International, Ltd.

    K Number Device Name
    K072519 ACTIVATOR V SPINAL ADJUSTING INSTRUMENT
    K003185 FS ACTIVATOR III