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    K Number
    K040849
    Device Name
    MENTAMOVE
    Manufacturer
    COLE & ASSOCIATES
    Date Cleared
    2004-10-01

    (183 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K012885
    Why did this record match?
    Device Name :

    MENTAMOVE

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

    Mentamove is indicated for use in the rehabilitation of victims of stroke. It utilizes stroke victims' electromyographic signals to guide the application of electrical muscle stimulation. This stimulation helps stroke victims to relearn voluntary motor functions of the extremities.

    Device Description

    Mentamove is a microprocessor controlled medicotechnical instrument that provides electromyography (EMG)-triggered neuromuscular electrical stimulation ("EMS").

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance, or details of a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary and FDA clearance letter for the Mentamove® device, establishing its substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested table and study details. The available information primarily focuses on:

    • Applicant and Manufacturer: Cole & Associates and pIfR Privat-Institut für Reha-Anwendungen GmbH & Co.
    • Device Name: Mentamove®
    • Common Name and Classification: Powered Muscle Stimulator, Biofeedback Device (Class II)
    • Predicate Device: Neuromove NM900 (K012885)
    • Device Description: Microprocessor controlled medicotechnical instrument providing electromyography (EMG)-triggered neuromuscular electrical stimulation ("EMS").
    • Intended Use and Indications: Rehabilitation of stroke victims to relearn voluntary motor functions of the extremities by using EMG signals to guide electrical muscle stimulation.
    • Technological Characteristics: User-friendly, self-explanatory instructions, automatic adjustment of parameters, simple electrode placement, optical signal transmission, automatic gauging of therapeutic advances, amplitude modulated electrical current.
    • FDA Clearance: The FDA determined the device is substantially equivalent to legally marketed predicate devices.

    To answer your specific questions, information from clinical trials, verification and validation studies, or performance testing would be required, which is not present in the provided 510(k) summary.

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