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510(k) Data Aggregation
K Number
K081279Device Name
PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000
Manufacturer
Date Cleared
2009-01-23
(262 days)
Product Code
Regulation Number
882.1320Why 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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