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510(k) Data Aggregation

    K Number
    K120835
    Device Name
    DYNATRON THERMOSTIM PROBE-DONE
    Manufacturer
    DYNATRONICS CORPORATION
    Date Cleared
    2012-08-20

    (153 days)

    Product Code
    GXY, DYN, ILO
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    DYNATRONICS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A hand held cutaneous electrode to be used with Dynatronics Solaris devices to apply electrical stimulation and apply heat and cooling to the skin
    Device Description
    The Dynatron ThermoStim probes are used to provide therapeutic electrical stimulation and thermal therapy treatments. The probes consist of a handle with a treatment head and connections for a lead wire and/or circulating water. The probes act as an electrode for therapeutic electrical current provided by a Dynatron Solaris device, or other similar Dynatronics electrical stimulation devices in the delivery of electrical stimulation therapy. The treatment head transfers thermal energy (hot or cold) from circulating water when connected to a Dynatron QUAD7™. The probes are a passive, manual therapy accessory. Treatment cycles are controlled through previously cleared Dynatronics electrical stimulation and OUAD7 devices. There are two versions of the probe face - a flat head with a surface area of 11.4 cm2 (1.5," diameter) and a domed head with a surface area of 12.3cm-(1.1" diameter).
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