ReActiv8 Magnet - Implantable stimulator control magnet
Access comprehensive regulatory information for ReActiv8 Magnet - Implantable stimulator control magnet 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.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
The patient magnet is used to turn an implanted pulse generator (IPG) (Reactiv8) on and off. 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.