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    K Number
    K040193
    Device Name
    MODEL GST-1
    Manufacturer
    MEDICAL EQUIPMENT DEVICE SPECIALISTS
    Date Cleared
    2004-04-27

    (90 days)

    Product Code
    GZJ,IPF
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    K040455
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    AS A POWERED MUSCLE STIMULATOR

      1. Relaxation of muscle spasms
    • Prevention or retardation of disuse atrophy 2 .
    • Increasing local blood circulation
      1. Muscle re-education
    • Immediate post-surgical stimulation of calf muscles to 5. prevent venous thrombosis
      1. Maintaining or increasing range of motion

    AS A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR

    • 1 . Symptomatic relief of chronic intractable pain
    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a device named GST-1, which functions as a Transcutaneous Electrical Nerve Stimulator (TENS) and a Powered Muscle Stimulator.

    This document does not contain information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications for a study. The letter only confirms that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.

    Therefore, I cannot provide the requested information based on the given text.

    To answer your request, clinical study reports or summaries, often found within the 510(k) submission itself (which is typically a much larger document than this letter), would be needed. This FDA letter is a regulatory approval notice, not a scientific study report.

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