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510(k) Data Aggregation

    K Number
    K233536
    Device Name
    Air Compression Recovery System
    Manufacturer
    Shenzhen Dongjilian Medical Tech Co., Ltd.
    Date Cleared
    2023-12-16

    (43 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 Recovery System is intended for the temporary relief of minor muscle aches and for the temporary increase in circulation to the treated areas, it can simulate kneading and stroking of tissues by using an inflatable garment.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for an "Air Compression Recovery System." It discusses regulatory aspects, such as classification, general controls, quality system regulations, and adverse event reporting.

    However, it does not contain any details about clinical studies, performance data, acceptance criteria, sample sizes for training or test sets, ground truth establishment, or expert involvement in product validation. The letter solely confirms the device's substantial equivalence to predicate devices and outlines the regulatory obligations of the manufacturer.

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