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510(k) Data Aggregation

    K Number
    K041146
    Device Name
    CONTROL SOLUTIONS, INC., MODEL CS3102 HVG
    Manufacturer
    CONTROL SOLUTIONS, INC.
    Date Cleared
    2004-06-08

    (36 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K041140
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Relaxation of muscle spasm .
    • Increasing local blood circulation .
    • Maintaining or increasing range of motion •
    • Preventing or retarding disuse atrophy .
    • Muscle re-education .
    • Intusion is outcales. .
    Device Description

    CS3102 High Voltage Galvanic Stimulator

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called the "CS3102 High Voltage Galvanic Stimulator." It outlines the device's indications for use and confirms its substantial equivalence to legally marketed predicate devices.

    The document does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about a study, sample sizes, data provenance, expert qualifications, or adjudication methods for establishing ground truth.
    • Information about MRMC comparative effectiveness studies or standalone algorithm performance.
    • Details on how ground truth was established for training or test sets.

    Therefore, I cannot fulfill your request based on the provided input.

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