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510(k) Data Aggregation

    K Number
    K020684
    Device Name
    FINESUN EMS STIMULATOR
    Manufacturer
    FINESUN WORLDWIDE INTL. CO., LTD.
    Date Cleared
    2002-05-23

    (80 days)

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

    For model FS-004

    • Relaxation of muscle spasms
      For models FS-008, FS-012, FS-016 and FS-020
    • Relaxation of muscle spasms
    • Prevention or 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

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Finesun EMS Stimulator. It does not contain information about acceptance criteria or a study proving device performance.

    Therefore, I cannot answer your specific questions as the required information is not present in the provided text. This letter is focused on regulatory clearance and substantial equivalence to a predicate device, not on clinical performance studies or specific acceptance criteria for performance metrics.

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