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510(k) Data Aggregation

    K Number
    K062792
    Device Name
    ERCHONIA IOTO_240
    Manufacturer
    ERCHONIA MEDICAL, INC.
    Date Cleared
    2007-03-01

    (164 days)

    Product Code
    EGJ
    Regulation Number
    890.5525
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ERCHONIA IOTO_240

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

    The Erchonia IOTO_240 is a galvanic generator that is indicated for use in tap water iontophoresis to treat palmer hyperhidrosis and plantar hyperhidrosis.

    Device Description

    The Erchonia IOTO_240 is a galvanic generator.

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) premarket notification letter from the FDA regarding the "Erchonia IOTO 240" iontophoresis device. It confirms the device's substantial equivalence to a predicate device and outlines regulatory compliance.

    However, the document does not contain any information regarding acceptance criteria, study details, device performance data, sample sizes, expert qualifications, adjudication methods, details of a multi-reader multi-case study, standalone algorithm performance, or ground truth establishment relevant to the questions you've asked.

    The document primarily focuses on the regulatory approval process and states the intended indications for use, but it does not include the detailed technical and clinical study information you are seeking.

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