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510(k) Data Aggregation

    K Number
    K153456
    Date Cleared
    2016-06-14

    (196 days)

    Product Code
    Regulation Number
    890.5290
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Megapulse III Shortwave Diathermy

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

    Diathermy is used therapeutically to increase the temperature of tissues. It is generally accepted that heat produces the following desirable therapeutic effects:

    • · Relieves pain
    • · Increases the extensibility of collagen tissues
    • · Decreases joint stiffness
    • · Relieves muscle spasm
    • Increases local blood flow

    Megapulse Shortwave Diathermy system is indicated for use in the following conditions or applications:

    • · Disorders of the musculoskeletal system
      • o Muscle spasm
      • o Joint stiffness
      • o Joint contractures
    • · Chronic inflammatory or infective conditions
      • o Tenosynovitis
      • o Bursitis
      • o Synovitis
      • o Chronic inflammatory pelvic diseases
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer, along with the device's indications for use. It primarily focuses on the regulatory approval of the "Megapulse III Shortwave Diathermy" device based on substantial equivalence to existing devices.

    This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods. It does not present data from a study proving the device meets specific performance criteria.

    Therefore, I cannot provide the requested table and information as it is not present in the given text.

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