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510(k) Data Aggregation

    K Number
    K982830
    Date Cleared
    1998-11-06

    (87 days)

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

    FORTE, MODELS CPS 400 COMBO, CPS 200 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 conditions 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. The Forte CPS Combo, while using any of the applicators available for this device, can provide therapeutic deep heating between 40° and 45°C in all of its operating modes.

    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 Interferential, Microcurrent, 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

    This document is a 510(k) clearance letter from the FDA for several medical devices manufactured by Chattanooga Group, Inc. It states that the devices (Forte CPS 400 Stim, Forte CPS 200 Stim, Forte CPS Ultrasound, Forte CPS 400 Combo, and Forte CPS 200 Combo) are substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria. It is a regulatory clearance based on substantial equivalence, not a detailed technical report of performance testing.

    Therefore, I cannot provide the requested information based on the input text. The input text focuses on regulatory approval, product codes, trade names, and intended uses, not on performance metrics, study designs, or ground truth establishment.

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