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510(k) Data Aggregation

    K Number
    K042881
    Device Name
    PMD-2000 INTERFERENTIAL STIMULATOR
    Date Cleared
    2004-11-18

    (30 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHOENIX MEDICAL DEVICES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Interferential Current Mode: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post surgical and post traumatic pain. Neuromuscular Stimulator Mode: Relaxation of muscle spasm, increasing local blood circulation, maintaining and increasing range of motion, preventing or retarding disuse atrophy, muscle re-education, and immediate post surgical stimulation of calf muscles to prevent venous thrombosis.
    Device Description
    The PMD-2000 Interferential Stimulator is a battery or AC wall adapter powered device intended for clinic, and outpatient use. Once prescribed by a physician it gives the clinician a variety of electrotherapy modes to treat a range of indications. The PMD-2000 is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. The PMD-2000 incorporates the following features: - Two independent stimulation channels, which provide true interferential current and neuromuscular stimulation. - Continuous or pulsed stimulation. Various sweep and ramp times. - Adjustable amplitude and frequency. - Fifteen preset therapy protocols. - Pause button to allow temporary suspension of treatment and a resume button to allow the resumption of treatment. When a treatment session is paused, the timer does not countdown. Upon resumption of treatment, the timer resumes its countdown and the amplitude (intensity) is reset to zero. - Easy to connect, easy to handle, patient lead wire/cable assembly with a "one way" connector and color coded lead wires contribute to improved patient experience and improved therapy outcomes. - Timed therapy sessions. - Double A (AA) battery system accommodates standard alkaline, NiCad and Nickel Metal Hydride batteries. - The PMD-2000 user interface incorporates a 16 character (8x2) Liquid Crystal Display (LCD) and tactile switches for menu navigation.
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