đź“‹ FDA Reference
emg surface digital ring bar grounding eeg
Nicolet Biomedical Instruments
Summary: The EMG Surface Digital Ring Bar Grounding EEG is a diagnostic tool used primarily in neurology to measure electrical activity in the brain and muscles. It is used by neurologists and other specialists to diagnose and monitor neurological conditions.
FDA Clearance Information
Pathway
510K
Number
K850108 ↗
Decision Date
April 11, 1985
Product Code
GXY
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on April 11, 1985, by Nicolet Biomedical Instruments. It is classified as a Class 2 device under product code GXY.
What It Is
The EMG Surface Digital Ring Bar Grounding EEG is a non-invasive diagnostic device that records electrical activity from the brain and muscles. It uses surface electrodes, typically placed on the scalp, to capture EEG signals and assess neuromuscular function. This device helps clinicians evaluate brain wave patterns and muscle activity, providing critical data for diagnosing conditions such as epilepsy, sleep disorders, and neuromuscular diseases.
Clinical Applications
This device is commonly used in neurology clinics and hospitals for diagnosing and monitoring conditions like epilepsy, sleep disorders, and neuromuscular diseases. It is particularly useful in settings where continuous monitoring of brain activity is required, such as epilepsy monitoring units or sleep study centers. The device is suitable for a wide range of patient populations, including pediatric and adult patients.
Indications for Use
The FDA indications suggest that this device is intended for use in recording and monitoring electrical activity in the brain and muscles. It is particularly useful for patients with suspected neurological disorders, such as epilepsy or neuromuscular conditions.
Practical Considerations
The device typically comes with various electrode sizes to accommodate different patient needs. It is compatible with standard EEG systems and requires proper electrode placement for accurate readings. Clinicians should be familiar with EEG interpretation and ensure that the device is calibrated correctly before use.
Frequently Asked Questions
What is EMG Surface Digital Ring Bar Grounding EEG used for?
It is used to record and monitor electrical activity in the brain and muscles, aiding in the diagnosis of neurological conditions like epilepsy and sleep disorders.
What specialties typically use this device?
Neurologists and sleep specialists commonly use this device in clinical settings such as hospitals and specialized clinics.
What are the FDA-cleared indications?
The device is cleared for recording and monitoring electrical activity in the brain and muscles, useful for diagnosing neurological disorders.
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.