Intronix Technologies Corporation

Address:26 McEwan Drive, Unit 15,BOLTON Ontario,CA

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stimulator, Nerve, Battery-Powered (BXN) (1)

Premarket Exempt

Yes

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Myoguide System Model 8008 - 00627843471783 Catalog Number : 8008

Device Description : The Intronix Model 8008 Myoguide system (Myoguide) is a medical device that oper The Intronix Model 8008 Myoguide system (Myoguide) is a medical device that operates as an electromyography (EMG) amplifier with onboard stimulator and signal display. It is intended for use to amplify muscle signals (EMG) from muscle and provide audio and visual feedback to assist clinicians in locating areas of muscle activity. The stimulator can be used for nerve localization or to invoke a muscle twitch. These features provide feedback used for guidance of injections into muscle or in the vicinity of nerves. This device is a battery powered, handheld, EMG amplifier with audio feedback and stimulator, LCD EMG signal and device status display, and current stimulation ranging from 0 mA - 20 mA.

Device Class : 2

Duns Number: 249192931

Premarket Exempt : Yes

Product Code : BXN

Prescription Use : Yes

Device Count : 1

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