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510(k) Data Aggregation

    K Number
    K123561
    Device Name
    ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS
    Manufacturer
    BSN MEDICAL, INC.
    Date Cleared
    2012-12-18

    (29 days)

    Product Code
    DWL
    Regulation Number
    880.5780
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS

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

    For the management of lymphedema and other edema.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA for medical support stockings (Elvarex / Elvarex Soft / Elvarex Soft Seamless). This document does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for AI/algorithm-based devices.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the given text. This document is a regulatory clearance letter, not a clinical study report or a technical performance evaluation.

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