FDA.reportPublic FDA data

INTRONIX TECHNOLOGIES CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30001550353000155035INTRONIX TECHNOLOGIES CORPORATION1N2020-04-2526 McEwan Drive, Unit 15 BOLTON Ontario CA L7E 1E6

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1374981314931291K111985MYOGUIDE SYSTEM MODEL 8008BXN2011-12-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BXN12011-12-30

PMN#

GUDID#

Myoguide System Model 8008 - 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.

Intronix Technologies Corporation

2016-09-23