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510(k) Data Aggregation
K Number
K111985Device Name
MYOGUIDE SYSTEM MODEL 8008
Manufacturer
INTRONIX TECHNOLOGIES CORP.
Date Cleared
2011-12-30
(171 days)
Product Code
BXN, SEC
Regulation Number
868.2775Why did this record match?
Applicant Name (Manufacturer) :
INTRONIX TECHNOLOGIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intronix Model 8008 Myoguide System (Myoguide) is a medical device intended as a stimulator for nerve localization as well as an aid for guidance of injections into the muscles.
Device Description
Myoguide is a battery powered, handheld, EMG amplifier with audio feedback, LCD EMG signal and device status display, and current stimulation ranging from 0 mA - 20 mA. This device is internally powered and rated for continuous use. The patient input connection is a type BF applied part. Myoguide will automatically power off after 30 minutes of inactivity to conserve battery life.
Myoguide is designed to amplify electrophysiological signals from muscle and provide audio feedback to assist clinicians in locating areas of muscle activity. The Stimulator can be used as an adjunct. Myoguide provides muscle and nerve localization information, to accurately guide and monitor needle electrode insertion, and/or injection of neuromodulator drugs, into a muscle in the human body. Any drug used will be that of the physician.
The large LCD display provides the complete system status at a glance. EMG audio, EMG signal display, EMG RMS Value, Integrated EMG signal strength and stimulation capability, increases efficacy for injection point localization. The simple control panel is intuitive and easy to operate.
Myoguide operates in two modes: "[EMG]" and "[Stimulation]". The default mode, "[EMG]", records electromyographic (EMG) signals from electrodes placed on the subject. The second mode, "[Stimulation]", enables Myoguide's onboard stimulator to stimulate through the needle electrode that was used to record the EMG. This enables the clinician to record and stimulate through the same needle electrode. The <Mode> switch is used to change the state of operation.
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