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510(k) Data Aggregation

    K Number
    K041714
    Device Name
    E-PAIN CARE
    Manufacturer
    BREG, INC.
    Date Cleared
    2004-10-01

    (100 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    E-PAIN CARE

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

    BREG's e-PAIN CARETM is intended to provide infusion of a 'local anesthetic into an intra-operative site for the post-operative management of pain.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA to Breg, Inc. for their "E-Pain Care" device. This document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

    The letter primarily focuses on the FDA's determination of substantial equivalence to a predicate device, allowing the company to market the E-Pain Care device. It lists the device name, regulation number, regulatory class, and product code, and clarifies the "Indications for Use."

    Therefore, I cannot extract the information asked for in your request from this document.

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