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510(k) Data Aggregation

    K Number
    K093951
    Device Name
    OUCHLESS MODEL PN10114
    Manufacturer
    OCCAM DESIGN
    Date Cleared
    2010-06-15

    (174 days)

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

    OUCHLESS MODEL PN10114

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

    Use like ice for the temporary relief of minor localized pain.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for a device named "Ouchless." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically seen in submissions for AI/ML-driven medical devices.

    The "Ouchless" device is classified as "Unclassified" and its indication for use is "Use like ice for the temporary relief of minor localized pain." This suggests a non-AI, physical or chemical product rather than a diagnostic or therapeutic AI software device.

    Therefore, I cannot provide the requested information based on the given input. The document is strictly a regulatory clearance letter acknowledging substantial equivalence to existing devices for a low-risk, non-AI product.

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