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510(k) Data Aggregation

    K Number
    K030878
    Date Cleared
    2003-03-28

    (8 days)

    Product Code
    Regulation Number
    890.5300
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The indications for use are: - Relief or reduction of pain; 1. - Reduction of muscle spasm; 2. - Joint contracture; and 3. - Local increase in circulation. 4.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA to Metron Medical Australia Pty. Ltd. for a device called "Accusonic, Model AS-270," which is classified as an Ultrasonic Diathermy device.

    This document does not contain any information about acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set information.

    The letter confirms that the FDA has reviewed the 510(k) submission and determined the device to be substantially equivalent to legally marketed predicate devices for the stated indications for use:

    • Relief or reduction of pain
    • Reduction of muscle spasm
    • Joint contracture
    • Local increase in circulation

    The document is a notification of regulatory clearance, not a technical report or scientific study detailing how the device met specific performance criteria through testing. Therefore, I cannot provide the requested information based on this document.

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