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510(k) Data Aggregation

    K Number
    K992372
    Device Name
    THE LEADAWAY
    Manufacturer
    THERAPY EQUIPMENT, INC.
    Date Cleared
    1999-10-13

    (90 days)

    Product Code
    IKD
    Regulation Number
    890.1175
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    THE LEADAWAY

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

    The Leadaway is to be used as a lead wire for electrotherapy devices.

    Device Description

    Not Found

    AI/ML Overview

    The provided documents are a letter from the FDA to Therapy Equipment, Inc. regarding the 510(k) premarket notification for "The Leadaway" device. The letter determines that the device is substantially equivalent to legally marketed predicate devices and states its intended use. However, this document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the input provided. The document focuses solely on the regulatory approval of the device based on substantial equivalence.

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