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510(k) Data Aggregation

    K Number
    K021238
    Device Name
    FRYE ADJUSTING INSTRUMENT
    Manufacturer
    FRYE HEALTH SYSTEMS
    Date Cleared
    2002-10-09

    (174 days)

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

    FRYE HEALTH SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Frye Adjusting Instrument is intended for chiropractic adjustment of the spine and extremities.
    Device Description
    The Frye Adjusting Instrument is a chiropractic, adjusting instrument for use in spinal manipulative therapy. The Frye Adjusting Instrument is a modification of the Full Spectrum Activator® III Adjusting Instrument developed to offer easier use to those chiropractors that have limited strength or dexterity in their hands. Typically, these are chiropractors that have arthritis, age-related problems, or have a physical disability of their upper extremity. Thus, these chiropractors have difficulties using currently available adjusting instruments. The main differences between currently available adjusting instruments, such as the FS Activator® III, and the Frye adjusting instrument are that the Frye adjusting instrument is activated pneumatically by a simple push-button and it is shaped in a 'gun-like' configuration rather than a 'plunger-like' configuration.
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