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510(k) Data Aggregation

    K Number
    K971708
    Device Name
    PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE
    Manufacturer
    J & J ENGINEERING, INC.
    Date Cleared
    1998-02-18

    (286 days)

    Product Code
    HCC,NOV
    Regulation Number
    882.5050
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended to be used for physiological monitoring, biofeedback training, incontinence, relaxation training, muscle reeducation and research.

    Device Description

    Physiological Monitoring & Biofeedback Instrument

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) clearance letter for the "J&L I-410 Physiological Monitoring & Biofeedback Instrument" (K971708) does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

    The document is a standard FDA clearance letter, which states that the device is "substantially equivalent" to predicate devices and can therefore be marketed. It outlines regulatory requirements and provides contact information. It does not include technical specifications, performance metrics, or details of any studies conducted to validate the device's performance against specific acceptance criteria.

    Therefore, I cannot provide the requested information in the table or answer the subsequent questions based on the provided text.

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