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510(k) Data Aggregation

    K Number
    K123820
    Date Cleared
    2013-04-02

    (111 days)

    Product Code
    Regulation Number
    880.5780
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOSSONG HOSIERY MILLS, INC

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

    8-15 mmHg Mild For tired, aching legs, minor leg swelling, leg pain, poor blood circulation 8
    10-20 mmHg Anti-Embolism Stocking - Helps prevent edema and leg discomfort, and helps prevent deep vein thrombosis (DVT) in patients subjected to immobility.
    15-20 mmHg Moderate Firm - For mild varicose veins, post surgery, poor blood circulation, leg discomfort, mild to moderate swelling, tired and aching legs - Helps prevent deep vein thrombosis for long distance travelers and edema
    20-30 mmHg - For varicose veins, post surgery, venous insufficiency, moderate to severe varicosis, moderate swelling - Helps prevent deep vein thrombosis for long distance travelers and edema
    30-40 mmHg Extra Firm - For edema, after healing of leg ulcers, severe chronic venous insufficiency, postphlebitic syndrome, post deep vein thrombosis (DVT), advanced varicose veins, phlebitis and reversible lymphedema - Post varicose vein surgery, vein stripping, sclerotherapy, plebectomy

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for "Bossong Hosiery Medical Support Stockings." It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain information on acceptance criteria, a study proving device performance against those criteria, or any of the detailed study parameters requested (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance). The letter is a regulatory approval document and not a scientific study report.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study that proves the device meets those criteria, as this information is not present in the provided document.

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