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510(k) Data Aggregation

    K Number
    K982317
    Device Name
    VECTRA COMBO
    Date Cleared
    1999-02-01

    (214 days)

    Product Code
    Regulation Number
    890.5860
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VECTRA COMBO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For Ultrasound: Ultrasound for use in applying deep heat can be used for treatment of selected medical Childious such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis, bursitis with slight calcification, myositis and soft tissue injuries. Ultrasound can provide therapeutic deep heating between 40° and 45°C.

    For VMS, Russian, Monophasic Hi-Volt:

    • Relaxation of muscle spasms
    • Prevention or retardation of disuse atrophy
    • Increasing local blood circulation 1
    • Muscle re-education
    • Maintaining or increasing range of motion
    • Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

    For Microcurrent, Interferential and Premodulated:

    • = Symptomatic relief of chronic, intractable pain
    • Management of pain associated with post-traumatic or post-operative conditions
    Device Description

    Not Found

    AI/ML Overview

    I am sorry but I am unable to answer your request. The document provided does not contain information about acceptance criteria, device performance, sample sizes, or study details. It is a letter from the FDA regarding 510(k) premarket notification for several medical devices, confirming their substantial equivalence to previously marketed devices and outlining regulatory requirements.

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