Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K223775
    Device Name
    EZ-STIK Electrodes
    Date Cleared
    2023-01-03

    (18 days)

    Product Code
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    South Dakota Partners

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EZ-STIK Electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the electrical stimulator. The EZ-STIK Electrodes are designed and intended to be used with marketed electrical stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscle Stimulation), IF (Inferential), or PGF (Pulsed Galvanic Stimulation). The electrode is for OTC (Over-the-Counter) or Prescription Use.
    Device Description
    EZ-STIK Electrodes have a basic 3-layer construction of non-woven polyester material or soft PVC foam, carbon film coated with silver and conductive hydrogel. EZ-STIK Electrodes are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application. First layer: Insulating backing material- non-woven polyester material or soft PVC foam coated with biocompatible medical adhesive tape Second layer: Conductive carbon-carbon film or Carbon film/Carbon film coated with silver film Third layer: Biocompatible self-adhesive conductive hydrogel The electrodes are designed for single-patient/multiple application use. Because of the biocompatible conductive hydrogel's adhesive nature, no securing materials are required to secure the device to the patient's skin. The electrode is connected to the electrical stimulator by lead wire, with a standard .080" female socket connector. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages. Wire assembly complies with FDA performance standard 21 CFR Part 898.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1