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510(k) Data Aggregation
K Number
K170744Device Name
Adhesive Electrodes
Manufacturer
Date Cleared
2017-05-08
(59 days)
Product Code
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
Reno Medical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Adhesive electrodes are intended for use as the disposable, conductive interface between the patient's skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
Device Description
Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
The proposed device, Adhesive Electrode, is intended to be used with U.S. legally marketed Electrical Stimulator, i.e. TENS and EMS, as a conductive adhesive interface between the patient's skin and such stimulators. It is for single patient use only.
The intended environment for the proposed device includes home use and hospital use. The intended population for the proposed device includes children and adults.
The proposed device mainly consists of substrate and wire. The substrate is available in rectangular shape and round shape.
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