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510(k) Data Aggregation

    K Number
    K171387
    Device Name
    EMS100 Tri-Wave Combination Stimulator
    Date Cleared
    2017-05-31

    (20 days)

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

    Elite Medical Supply of New York, 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
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