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510(k) Data Aggregation
K Number
K223775Device Name
EZ-STIK Electrodes
Manufacturer
Date Cleared
2023-01-03
(18 days)
Product Code
Regulation Number
882.1320Why 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.
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