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510(k) Data Aggregation

    K Number
    K982828
    Date Cleared
    1998-11-06

    (87 days)

    Product Code
    Regulation Number
    890.5850
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FORTE, MODELS CPS 400 STIM, CPS 200 STIM

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

    For VMS, Russian, Monophasic Hi-Volt:

    • Relaxation of muscle spasms
    • Prevention or retardation of disuse atrophy
    • Increasing local blood circulation
    • 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

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for several medical devices. It does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment.

    Therefore, I cannot provide the requested information. The document primarily confirms the substantial equivalence of the listed devices to pre-amendment devices and outlines regulatory obligations for the manufacturer.

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