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510(k) Data Aggregation
K Number
K180865Device Name
ZMI Self-Adhesive Electrodes
Manufacturer
ZMI Electronics, Ltd.
Date Cleared
2018-06-28
(87 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
ZMI Electronics, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ZMI Self-adhesive electrodes are intended for use as a reusable, conductive interface between the patient's skin and the marketed electrical stimulators (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrodes are for OTC (Over-The-Counter) or Prescription use.
Device Description
ZMI Self-adhesive electrodes provide a means for establishing electrical contact between the lead connected to a TENS, EMS or NMES stimulation device and the skin, and are multi-layer, reusable, flexible structures composed of laminated materials commonly used in the application:
Top laver: Insulation material: Fabric/foam/tan fabric
Middle layer: Conductive film (Silver coated Carbon film/Aluminum foil film)
Bottom layer: Biocompatible self-adhesive conductive hydrogel
Connection: Leadwire/snap button/magnetic button
The electrodes are designed for single-patient & multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, no securing materials are required to secure the device to the patient's skin.
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