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510(k) Data Aggregation

    K Number
    K081279
    Device Name
    PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000
    Date Cleared
    2009-01-23

    (262 days)

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

    TRANSFER TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Transfer Technology PRO-TECH Delivery System electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator Transfer Technology's reusable electrodes are designed and intended to be used with marketed, Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), and MANS (Muscle and Neurological Stimulators)
    Device Description
    Transfer Technology reusable neurostimulator electrodes are laminated flexible materials widely used in this application. Top layer Vinyl tape or non-woven fabrics with biocompatible adhesive Second layer Grade "A" pure tin or electrically conductive carbon with Ag or Ag/AgCl Third layer 1.25" flexible vinyl tape with biocompatible adhesive laminated around the outer perimeter of electrode Patient layer Conductive hydrogel Amgel AG703 Lead Wire Constructed of a silicone-insulated stainless steel yarn wire with a standard 080" recessed female contact crimped and then insulated to one end By design, the insulated contact prevents the conductive connection to earth or hazardous voltages as required in IEC 60601-1 Subclause 56 3(c) Wire assembly is in compliance with FDA performance standard 21 CFR Part 898
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