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510(k) Data Aggregation

    K Number
    K972997
    Device Name
    AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION
    Manufacturer
    DAN MED, INC.
    Date Cleared
    1997-11-10

    (90 days)

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

    AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION

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

    Stroke Rehab by Muscle Reeducation Relaxation of muscle spasms. Prevention of retardation of disuse atrophy. Increasing local blood circulation. Muscle re-education. Maintaining or increasing range of motion.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "AM800 AutoMove EMG Triggered Electrical Muscle Stimulation" device.

    This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

    The letter is a notification of substantial equivalence to a legally marketed predicate device, allowing the device to be marketed. It does not include the technical details or study reports that would contain the requested information about device performance and validation.

    Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.

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