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510(k) Data Aggregation
K Number
K171381Device Name
Adhesive Electrodes
Manufacturer
ShenZhen Quality Medical Technology Co.,Ltd
Date Cleared
2017-12-13
(216 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
ShenZhen Quality Medical Technology Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Adhesive Electrodes are intended to transmit electrical current to patient skin for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation) applications. It is for OTC (Over-The -Counter) or Prescription use and is to be used for adults only.
Device Description
The Adhesive Electrodes transmit electrical current to patient skin, the electrical current is first transmitted via the snap button then transmitted to the conductive gel which is adhered to patient skin. Adhesive Electrodes are multi-layer reusable, flexible structures, composed of laminated materials commonly used in this application: EVA foam First layer: Insulating backing material: Second layer: Conductive film: Carbon film Third layer: Biocompatible self-adhesive conductive hydrogel Protective liner: PET. The dimension of the adhesive electrode is 40 mm (L) × 70 mm (W) ×3mm (H).
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