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510(k) Data Aggregation

    K Number
    K072252
    Device Name
    VEINOPLUS NEUROMUSCULAR STIMULATOR
    Manufacturer
    ADREM TECHNOLOGY SARL
    Date Cleared
    2008-01-30

    (170 days)

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

    ADREM TECHNOLOGY SARL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VEINOPLUS® Neuromuscular Stimulator is indicated for the following: In the Primary Mode of Action (PMOA) when the Operating Mode number 1 for muscle stimulation is activated, the Indications for Use are: - · Relaxation of muscle spasms. - · Prevention or retardation of muscle disuse atrophy. - · Increasing local blood circulation. - · Muscle re-education. - · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - · Maintaining or increasing range of motion. In the other Mode of Action (MOA), when the Operating Mode number 2 for Transcutaneous Electrical Nerve Stimulation (TENS) stimulation is activated, the Indication for Use is : · Providing symptomatic pain relief for chronic, acute or post operative pain.
    Device Description
    The VEINOPLUS® Neuromuscular Stimulator is a traditional battery powered muscle stimulator and it is combined with the TENS stimulator. It is a single channel device with its Operating Modes stored in the internal memory. The VEINOPLUS® provides two separate and switchable independent Operating Modes of stimulation.
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