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510(k) Data Aggregation

    K Number
    K070931
    Device Name
    MODEL PMT850
    Manufacturer
    Date Cleared
    2007-05-24

    (51 days)

    Product Code
    Regulation Number
    890.5290
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROMEDTEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Model PMT850 is indicated for adjunctive use in the palliative treatment of postoperative edema and pain in superficial soft tissue.
    Device Description
    The Model PMT850 device is a pulsed shortwave diathermy device. The Model PMT850 system consists of a Generating Unit connected by a cable to the Treatment Applicator. The Treatment Applicator and cable are a single unit which is connected or disconnected easily from the Generating Unit. The Generating Unit connects to a standard AC electrical outlet by a grounded 3-prong UL/CSA approved, medically rated electric cord. Treatment with the Model PMT850 requires placing the Treatment Applicator on top of any standard dressing over the area to be treated, setting the dials on the Generating Unit, and turning the device on. There are 6 possible pulse frequency and 6 possible power control settings on the generating unit of the Model PMT850, providing 36 setting options for treatment. Suggested treatment settings are discussed in the Operating Manual for the Model PMT850.
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