ReActiv8 Activator - Implantable lumbar neuromuscular electrical stimulation system control unit - ARTG 327090
Access comprehensive regulatory information for ReActiv8 Activator - Implantable lumbar neuromuscular electrical stimulation system control unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 327090 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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An electronic component of an implantable lumbar neuromuscular electrical stimulation system (Reactiv8) intended to be used by a patient to telemetrically control its function (on/off) and delivery of treatment cycles. 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.