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510(k) Data Aggregation

    K Number
    K052875
    Device Name
    PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES
    Manufacturer
    SUMMIT MANUFACTURING, L.L.C.
    Date Cleared
    2005-12-27

    (76 days)

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

    SUMMIT MANUFACTURING, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ProStim Reusable Neurostimulation Electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. ProStim Reusable Neurostimulation Electrodes are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation).
    Device Description
    ProStim Reusable Neurostimulation electrodes arc non-sterile, disposable laminated. flexible structures composed of materials commonly used in this application: First Layer-White spun laced nonwoven tape or White 1/32" thick Polyethylene foam or a polypropylene substrate, coated with biocompatible adhesive. Second Layer- Conductive plastic film. Third Layer-Biocompatible conductive hydrogel coupling media. The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The electrode has one type of connection point that can be used to connect the stimulation device to the electrodes. This connection point is compatible with all standard, marketed Neurostimulation devices. Lead wire assembly - 6" wire with .080 in. diameter female socket connected to one side of the wire.
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