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510(k) Data Aggregation

    K Number
    K022433
    Device Name
    NEOGENESYS 2K
    Manufacturer
    Date Cleared
    2003-01-24

    (183 days)

    Product Code
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    SANEXAS INTL. GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PAIN MANAGEMENT Indications for Electromedical Treatment 1. For adjunctive treatment of post-traumatic pain syndromes. 2. For management and symptomatic relief of chronic (long-term) intractable pain. 3. As an adjunctive treatment in the management of post-surgical pain problems. MUSCLE STIMULATION Indications for Electromedical Treatment 1. Relaxation of muscle spasms. 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Muscle reeducation 5. Immediate post-surgical stimulation of calf muscle to prevent phlebothrombosis. 6. Maintaining or increasing range of motion Powered Muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
    Device Description
    This device is an electrical signal generator which applies sinusoidal current through two pairs of contact electrodes using temporal interference patterns to stimulate peripheral nerves for the purpose of providing pain relief or as an adjunctive treatment in physical therapy per guidelines in the indications for use. As an alternative, this device can perform the forementioned functions by applying sinusoidal current through only one pair of electrodes.
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