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510(k) Data Aggregation

    K Number
    K170415
    Device Name
    Medline Hemo-Force DVT Compression Sleeve
    Manufacturer
    Medline Industries, Inc.
    Date Cleared
    2017-09-08

    (210 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Medline Hemo-Force DVT Compression Sleeve

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

    The Medline Hemo-Force DVT compression sleeve is recommended for use in patients for whom external compression therapy is indicated to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the Medline Hemo-Force DVT Compression Sleeve. It asserts substantial equivalence to predicate devices but does not contain detailed information about acceptance criteria or specific study results that prove the device meets acceptance criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence, not on a detailed performance study with acceptance criteria.

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