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510(k) Data Aggregation

    K Number
    K162412
    Device Name
    Hoggan Scientific® microFET2™
    Manufacturer
    Hoggan Scientific, LLC
    Date Cleared
    2017-03-09

    (192 days)

    Product Code
    LBB
    Regulation Number
    888.1240
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hoggan Scientific, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The microFET2™ System is a dynamometer device for performing muscle tests to quantitatively measure muscle weakness caused by injury or for sports medicine applications, as well as measure general muscle strength. The device is used to record and convey an individual's ability to resist force for a specific muscle group being tested.
    Device Description
    The microFET2™ is an ergonomically designed hand-held, battery operated, digital muscle tester. Which is an accurate, portable Force Evaluation Testing (FET) dynamometer, designed specifically for taking objective, reliable, and quantifiable muscle testing measurements, and is used to record a person's ability to resist force for a specific muscle or muscle group being tested. The device's ergonomic design allows for its use ambidextrously, depending on stabilization requirements, by being held in either hand using an elastic strap for convenience and comfort. The size and weight of the device allows the examiner/tester to use the same procedures and methods of muscle testing techniques without causing injury to the clinician or patient.
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