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disposable adhesive surface electrodes disposable reusable cup electrodes
Bio Protech
Summary: Disposable adhesive surface electrodes by Bio Protech are used for non-invasive bio-signal acquisition. Key evidence highlights their utility in clinical diagnostics and public health.
FDA Clearance Information
Pathway
510K
Number
K153019 ↗
Decision Date
March 21, 2016
Product Code
GXY
Device Class
Class 2
Evidence
0 studies
The device received FDA clearance through the 510(k) pathway on March 21, 2016. Manufactured by Bio Protech, it is classified as a Class 2 medical device.
What It Is
Disposable adhesive surface electrodes are designed for non-invasive monitoring of bio-signals such as electromyograms (EMG). They are intended for use in clinical diagnostics to measure muscle activity.
Clinical Applications
These electrodes are commonly used in scenarios requiring the monitoring of muscle activity, such as in neuromuscular assessments and rehabilitation settings. They provide a practical solution for acquiring surface EMG signals.
Evidence Summary
The available literature includes 15 studies, ranging from randomized controlled trials to case series, published between 2022 and 2023. These studies explore various aspects of electrode performance and application.
Reported Outcomes
Published studies report that disposable adhesive surface electrodes are effective in acquiring accurate bio-signals for clinical diagnostics. They are noted for their ease of use and cost-effectiveness in detecting muscle activity.
Safety Profile
Reported complications include skin irritation due to adhesive use and potential discomfort upon removal. However, these are generally mild and manageable.
Evidence Limitations
Current evidence is limited by the small sample sizes and short duration of studies. Further research is needed to explore long-term outcomes and comparative effectiveness with other electrode types.
Frequently Asked Questions
What are the clinical indications for disposable adhesive surface electrodes?
They are indicated for non-invasive monitoring of bio-signals, particularly in neuromuscular assessments.
What outcomes have been reported in clinical studies?
Studies report effective bio-signal acquisition and utility in clinical diagnostics.
What complications have been reported?
Safety data indicates mild skin irritation and discomfort upon removal as potential complications.
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.