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510(k) Data Aggregation

    K Number
    K170291
    Device Name
    IontoDC
    Manufacturer
    SOTERIX MEDICAL,INC.
    Date Cleared
    2017-05-01

    (90 days)

    Product Code
    EGJ
    Regulation Number
    890.5525
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOTERIX MEDICAL,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IontoDC is intended to use a direct current to introduce ions of soluble salts or other drugs into the body.
    Device Description
    IontoDC is a bench-top, battery powered, microcontrollercontrolled iontophoresis device that delivers direct current to a drug delivery electrode placed on the patient's skin. This current expedites the migration of ionic drug solutions through the skin into localized tissue.
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