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510(k) Data Aggregation

    K Number
    K023230
    Device Name
    ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800
    Manufacturer
    WESTERN CLINICAL TECHNOLOGY SYSTEMS, INC.
    Date Cleared
    2003-05-05

    (220 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K891987
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Relaxation of muscle spasms

    Device Description

    The EchoPulse 800 is an eight channel, synchronous, biphasic, powered muscle stimulator. It produces a maximum output voltage of 105 V at 500 ohm, a maximum output current of 210 mA at 500 ohm and has a pulse width of 180 usec. The 3 pin connector leads are each 72 inches long. The electrodes are 3 inch diameter Carbonflex electrodes and use 3 inch disposable sponge fabric wetable pads for application on the skin. The EchoPulse 800 measures 19 inches wide, 5 1/4 inches tall, and 12 1/2 inches deep. It weighs 27 1/4 pounds and is rack mountable.

    AI/ML Overview

    The provided document is a 510(k) summary for the EchoPulse Muscle Stimulator System. It states that the device is substantially equivalent to a predicate device and outlines its description and indications for use. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.

    Therefore, I cannot fulfill your request for that specific information based on the provided text. The document is primarily a regulatory submission for market clearance, not a report of a performance study.

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