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510(k) Data Aggregation

    K Number
    K994062
    Device Name
    HMS NEUROMUSCULAR STIMULATOR
    Manufacturer
    HOME MEDICAL SERVICES, INC.
    Date Cleared
    2000-04-10

    (131 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOME MEDICAL SERVICES, INC.

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

    THE INDICATIONS FOR USE OF THIS POWERED MUSCLE STIMULATOR FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS:

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

    HMS Neuromuscular Stimulator, Model HMS-3

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a Neuromuscular Stimulator. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested table and study details. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use. It doesn't include the detailed technical or clinical study data that would be necessary to answer your questions.

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