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510(k) Data Aggregation

    K Number
    K251083
    Device Name
    Compact II
    Manufacturer
    Enraf-Nonius, B.V.
    Date Cleared
    2025-09-12

    (156 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K202031
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Compact II is indicated for:

    • 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; and
    • Maintaining or increasing range of motion.
    Device Description

    The Compact II device generates (or induces) electric current in targeted tissues. affected by a high induction magnetic field to stimulate those tissues to treat the indicated conditions.

    The device includes a transducer, which is used to provide the magnetic stimulation, which creates electrical fields by pulse current flowing from a capacitor according to the principle of Faraday's Law. Whenever the capacitor bank is discharged by the action of the control system, a pulse of current flows through the stimulating coil. The magnetic stimulation creates intense, rapidly changing magnetic electrical fields.

    The Compact II device consists of a console and transducer for magnetic stimulation. The function of magnetic stimulation is operated by adjusting parameters such as Mode, Intensity and Time. These parameters can be controlled by users on the LCD Touch Screen.

    AI/ML Overview

    N/A

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