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disposable pre-gelled surface electrode
Rochester Electro Medical
Summary: The disposable pre-gelled surface electrode by Rochester Electro Medical is used for surface electromyography (sEMG) to monitor muscle activity. Key evidence highlights its application in various clinical settings, including neuromonitoring during surgeries.
FDA Clearance Information
Pathway
510K
Number
K142159 ↗
Decision Date
June 3, 2015
Product Code
GXY
Device Class
Class 2
Evidence
0 studies
The disposable pre-gelled surface electrode was cleared by the FDA through the 510(k) pathway on June 3, 2015. Manufactured by Rochester Electro Medical, it is classified as a Class 2 device under product code GXY.
What It Is
The device is a disposable electrode pre-coated with conductive gel, designed for surface electromyography (sEMG). It is intended for non-invasive monitoring of muscle electrical activity, aiding in diagnosis and rehabilitation.
Clinical Applications
Commonly used in clinical scenarios such as intraoperative neuromonitoring during thyroidectomy and assessment of muscle activity in patients with prostheses. It provides a practical solution for continuous muscle monitoring.
Evidence Summary
The literature includes 8 studies, comprising randomized controlled trials and prospective studies, conducted between 2016 and 2025. These studies explore the device's efficacy in various clinical applications.
Reported Outcomes
Published studies report that the device effectively monitors muscle activity, with applications in neuromonitoring and prosthesis assessment. It has shown utility in both static and dynamic electromyographic measurements.
Safety Profile
Reported complications include potential skin irritation due to prolonged use of pre-gelled electrodes. No severe adverse events were noted in the reviewed studies.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of long-term outcome data. Further research is needed to explore the device's efficacy in diverse patient populations and settings.
Frequently Asked Questions
What are the clinical indications for disposable pre-gelled surface electrode?
The device is indicated for surface electromyography to monitor muscle activity, particularly in intraoperative neuromonitoring and prosthesis assessment.
What outcomes have been reported in clinical studies?
Studies report effective monitoring of muscle activity, with applications in neuromonitoring and prosthesis assessment.
What complications have been reported?
Reported complications include potential skin irritation from prolonged use of pre-gelled electrodes.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.