ReActiv8 Application Software - Implantable electrical stimulation device management software - ARTG 327093
Access comprehensive regulatory information for ReActiv8 Application Software - Implantable electrical stimulation device management software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 327093 and sponsored by Mainstay Medical Australia Pty Ltd, manufactured by Mainstay Medical Limited in Ireland. The device registration started on December 04, 2019.
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A software program intended to assist with the management of a ReActiv8 Implantable Pulse Generator. The Application Software provides a user interface that is used to program the IPG (change the value of the programmable parameters), interrogate the IPG (ask for the actual value of the programmable parameters, battery voltage, logged information and IPG status) and read the lead impedance (command the IPG to perform the procedure that allows it to calculate the lead impedance). The ReActiv8 System is indicated as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing. It should only be used in cases of chronic low back pain despite medical management and attempting at least one course of physical therapy.