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510(k) Data Aggregation

    K Number
    K061411
    Device Name
    TORBOT VASCULAR COMPRESSION GARMENTS
    Manufacturer
    TORBUT GROUP, INC.
    Date Cleared
    2006-10-18

    (149 days)

    Product Code
    DWL
    Regulation Number
    880.5780
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K925154,K963573,K991570,K001300,K021102,K013852
    Why did this record match?
    Applicant Name (Manufacturer) :

    TORBUT GROUP, INC.

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

    Torbot Vascular Compression Garments are intended to be used to apply pressure to the extremity and are indicated for use in the management of pooling of blood and/or lymphedema.

    Device Description

    Torbot Vascular Compression Garments, custom and ready-to-wear, help to prevent pooling of blood and fluid in the extremities by applying controlled graduated pressure. The fabric used is comprised of nylon and spandex which is used in the predicate devices.

    AI/ML Overview

    This document is a 510(k) summary for the Torbot Vascular Compression Garments, indicating substantial equivalence to predicate devices. It does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific study-related details requested in the prompt.

    Therefore, I cannot provide the requested table and study details. This submission focuses on regulatory equivalence rather than detailed performance testing.

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