ReActiv8 Programmer Wand - Implantable lumbar neuromuscular electrical stimulation system programmer
Access comprehensive regulatory information for ReActiv8 Programmer Wand - Implantable lumbar neuromuscular electrical stimulation system programmer in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is 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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An electronic component of an implantable lumbar neuromuscular electrical stimulation system (Reactiv8) intended to be used by a healthcare professional to telemetrically program the implantable pulse generator component with patient-specific parameters when connected to a commercially available laptop computer. The laptop computer is configured such that it can only be used with the Application Software. 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.