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510(k) Data Aggregation

    K Number
    K973223
    Device Name
    STELLAR MODEL HS-04
    Date Cleared
    1998-02-18

    (175 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    STELLAR MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Stimulator Mode: The Stellar Model HS-04 stimulator mode is indicated for use in repeatedly contracting muscles using pulsed electrical currents for muscle reeducation, maintaining or increasing range of motion, relaxing muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and immediate post-surgical prevention of venous thrombosis in the calf. Interferrential Mode: The Stellar Model HS-04 interferrential mode is indicated for use in post-surgical acute pain and edema, post-traumatic acute pain and edema, reduction of inflamation, increasing local blood circulation, maintaining or increasing range of motion, and relaxing muscle spasms. Heating Mode: The Stellar Model HS-04 heating mode is indicated for heating of a body region for the relief of minor muscular or joint pain.
    Device Description
    The Stellar Model HS-04 is a device that combines the functionality of two devices that have been classified by FDA, the powered muscle stimulator and the powered heating pad. Heat and muscle stimulation are often used at the same time by physical therapists and others to treat patients, and the HS-04 provides both therapies with a single combination device for convenience. The heating elements are contained in the same applicators that hold the stimulation electrodes.
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