ARTG 327089ReActiv8 Implantable Pulse Generator - Implantable lumbar neuromuscular electrical stimulation system pulse generator
ARTG ID: 327089 · Mainstay Medical Australia Pty Ltd · Mainstay Medical Limited · AIMD · Started December 04, 2019
Good Name: Mainstay Medical Australia Pty Ltd - ReActiv8 Implantable Pulse Generator - Implantable lumbar neuromuscular electrical stimulation system pulse generator
- Risk Class
- AIMD
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 327089
- Start Date
- December 04, 2019
- Effective Date
- December 04, 2019
- Country
- Ireland
- Address
- Clonmel House Forster Way Swords, Co Dublin, K67F2k3
A sterile, implantable, electronic component of an implantable lumbar neuromuscular electrical stimulation system (Reactiv8) intended to deliver episodic electrical stimulation to nerves that innervate lumbar muscles to elicit contraction for the treatment of chronic low back pain. 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.
Access comprehensive regulatory information for ReActiv8 Implantable Pulse Generator - Implantable lumbar neuromuscular electrical stimulation system pulse generator in the Australia medical device market through Pure Global AI's free TGA ARTG database. This AIMD is registered under ARTG number 327089 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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