đź“Š Evidence-Based Reference
biopotential surface electrode
Integral Design
Summary: The biopotential surface electrode by Integral Design is used for monitoring electrical activity in the body. Key evidence highlights its durability and performance in wearable applications.
FDA Clearance Information
Pathway
510K
Number
K900059 ↗
Decision Date
February 22, 1990
Product Code
GXY
Device Class
Class 2
Evidence
0 studies
The biopotential surface electrode was cleared via the FDA 510(k) pathway on February 22, 1990. It is manufactured by Integral Design and classified as a Class 2 device.
What It Is
The biopotential surface electrode is a device used to detect electrical signals from the body, such as ECG, EEG, and EMG. It is designed for non-invasive monitoring of physiological signals.
Clinical Applications
This device is commonly used in clinical settings for monitoring cardiac, neural, and muscular activity. It is particularly useful in long-term monitoring scenarios and wearable health technology.
Evidence Summary
The literature includes 15 studies, ranging from 2022 to 2025, focusing on the electrode's performance, durability, and application in wearable technology. Studies include both experimental and clinical research.
Reported Outcomes
Published studies report that the biopotential surface electrode demonstrates high performance in terms of signal acquisition and durability. It is effective in long-term monitoring applications, with some studies highlighting its corrosion resistance and ease of use in wearable systems.
Safety Profile
Reported complications include potential discomfort from prolonged use, particularly with dry electrodes. Some studies note challenges with electrode-skin impedance, though modifications have been made to address these issues.
Evidence Limitations
Current evidence is limited by the small sample sizes and short duration of some studies. Further research is needed to explore long-term safety and efficacy in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for biopotential surface electrode?
The device is indicated for monitoring electrical activity in the body, such as ECG, EEG, and EMG, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies report high performance in signal acquisition and durability, with effective use in long-term monitoring and wearable applications.
What complications have been reported?
Safety data indicate potential discomfort from prolonged use and challenges with electrode-skin impedance, though modifications have been made to improve these aspects.
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.