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510(k) Data Aggregation

    K Number
    K031769
    Device Name
    E-STRIP
    Manufacturer
    EEMSO, INC.
    Date Cleared
    2003-10-14

    (127 days)

    Product Code
    EGJ
    Regulation Number
    890.5525
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K872040,K914264,K992708
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The E-STRIP device is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes.

    Device Description

    The E-STRIP is an active; self- contained Iontophoretic Drug Delivery System. An Integrated battery mechanism within the butterfly-designed soft electrode provides the E-STRIP with the capacity to deliver safe and complete iontophoresis therapy. The delivery rate of medicine is determined by applied voltage, skin resistance, and Conductivity of the medication/ saline solution.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, or a study proving a device meets acceptance criteria. The document is a 510(k) summary for a medical device called "E-STRIP," which is an iontophoretic treatment system. It discusses general information about the device, its predicate devices, technological characteristics, and intended uses, along with the FDA's decision letter regarding its substantial equivalence. There is no mention of specific performance metrics, clinical studies, or data used to validate the device's efficacy or safety in the context of acceptance criteria.

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