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the electrode store surface cutaneous electrode for emg
The Electrode Store
Summary: The Electrode Store Surface Cutaneous Electrode for EMG is a device used for electromyography. It is primarily used to measure electrical activity in muscles. Key evidence includes studies on pain relief and metabolic functions.
FDA Clearance Information
Pathway
510K
Number
K020445 ↗
Decision Date
May 10, 2002
Product Code
GXY
Device Class
Class 2
Evidence
0 studies
The device was cleared by the FDA through the 510(k) pathway on May 10, 2002. It is manufactured by The Electrode Store and is classified as a Class 2 device under product code GXY.
What It Is
The Electrode Store Surface Cutaneous Electrode for EMG is designed to detect electrical activity in muscles, aiding in the diagnosis of neuromuscular disorders. It is intended for use in clinical settings by healthcare professionals.
Clinical Applications
This device is commonly used in scenarios requiring the assessment of muscle function, such as diagnosing conditions like neuropathies and myopathies. It is also used in rehabilitation settings to monitor muscle activity.
Evidence Summary
The available literature includes three studies, focusing on various aspects such as pain relief and metabolic functions. These studies are registered on clinical trial databases, though specific participant numbers and dates are not provided.
Reported Outcomes
Published studies report outcomes related to pain relief in neuralgia and metabolic functions in diabetes management. However, specific efficacy data is not detailed in the provided evidence.
Safety Profile
Reported complications include general concerns associated with cutaneous electrodes, such as skin irritation. The provided evidence does not specify further adverse events.
Evidence Limitations
The evidence lacks detailed efficacy and safety data, with no specific participant numbers or comprehensive study results. Further research is needed to establish more robust clinical outcomes.
Frequently Asked Questions
What are the clinical indications for the electrode store surface cutaneous electrode for EMG?
The device is indicated for use in measuring electrical activity in muscles, aiding in the diagnosis of neuromuscular disorders.
What outcomes have been reported in clinical studies?
Studies have reported outcomes related to pain relief and metabolic functions, though specific efficacy data is not detailed.
What complications have been reported?
Reported complications include skin irritation, a common issue with cutaneous 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.