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510(k) Data Aggregation

    K Number
    K973506
    Device Name
    ACTIVATOR II
    Manufacturer
    ACTIVATOR METHODS, INC.
    Date Cleared
    1998-01-27

    (133 days)

    Product Code
    LXM
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACTIVATOR METHODS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Activator II® is indicated for chiropractic adjustment of the spine and extremities.
    Device Description
    The Activator II ® is a chiropractic adjusting instrument for use in spinal manipulative therapy. The instrument is approximately seven (7) inches in length and approximately 2.5 inches wide at the handles. The major components of the device include handles for holding the device and applying thrust, a thrust element for delivering an input force to the patient, a body contact member, a spring for propelling the thrust element, and an adjustment knob. The body contact member is manufactured from silicone rubber. The adjustment knob is used for manually adjusting the amount of potential energy imposed on the spring and for controlling the magnitude of the resulting input force. When the handle is depressed, the body contact member applies the force in a specific line of drive at a rapid speed. This action is similar to a practitioner manually applying thumb thrust at specific contact points to achieve chiropractic adjustment.
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