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510(k) Data Aggregation

    K Number
    K213000
    Device Name
    Air Compression Massager (Model LF-FT003)
    Manufacturer
    Wenzhou Lingfeng Electronic Technology Co., Ltd
    Date Cleared
    2021-11-15

    (56 days)

    Product Code
    IRP
    Regulation Number
    890.5650
    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 Air Compression massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in good health. The Air Compression massager stimulates kneading and stroking of tissues by using an inflatable garment.

    Device Description

    Air Compression Massager (Model LF-FT003)

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for an Air Compression Massager (Model LF-FT003). It confirms that the device is substantially equivalent to legally marketed predicates and outlines regulatory requirements.

    However, the provided text does not contain any information about:

    • Specific acceptance criteria (e.g., performance metrics, thresholds) for the device.
    • Details of a study conducted to evaluate the device's performance against any criteria.
    • Sample sizes for test or training sets.
    • Data provenance.
    • Number or qualifications of experts used for ground truth.
    • Adjudication method.
    • Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
    • Whether a standalone performance study was done.
    • Type of ground truth used.
    • How ground truth for the training set was established.

    The document only provides the indications for use for the device. To answer your request, you would need to provide the actual performance study report or other documentation that details the testing and results for the Air Compression Massager.

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