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510(k) Data Aggregation

    K Number
    K024361
    Device Name
    EM PROBE, EM PAD
    Manufacturer
    EM PROBE INC.
    Date Cleared
    2003-10-09

    (283 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EM-PROBE is indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis, muscle spasm, and to increase local blood circulation.

    Device Description

    EM-PROBE

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to EM PROBE, Inc. regarding their device, EM-PROBE. This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or direct comparative effectiveness against human readers.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance based on the provided text. The document is primarily a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices, not a study report.

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