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510(k) Data Aggregation
K Number
K161282Device Name
FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W
Manufacturer
Date Cleared
2016-10-30
(177 days)
Product Code
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
MEDICO ELECTRODES INTERNATIONAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Reusable, self-adhering Neurostimulation Electrodes are indicated for use with transcutaneous electrical stimulation devices. Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices. Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.
Device Description
The FlexStim Neurostimulation Electrode is used as a transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS or EMS and available in backing materials such as, non-woven cloth and PE foam, conductive carbon film (low impedance and standard impedance) with lead wire and snap connection configurations. The device functions as a passive device by carrying an electrical signal from a neurostimulation device through the device cable and electrode lead wire or snap button to the user's skin.
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