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Orthosis, arm, elbow/wrist/hand, unit - ARTG 316193

Access comprehensive regulatory information for Orthosis, arm, elbow/wrist/hand, unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 316193 and sponsored by Darren Pereira, manufactured by Myomo Inc in United States of America. The device registration started on April 05, 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.

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TGA ARTG Official Data
Class I
ARTG 316193
Class I
Orthosis, arm, elbow/wrist/hand, unit
ARTG ID: 316193
Good Name: Darren Pereira - Orthosis, arm, elbow/wrist/hand, unit
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Intended Purpose

MyoPro is a powered orthosis designed to help restore function to arms and hands paralyzed or weakened by CVA stroke, brachial plexus injury, cerebral palsy or other neurological or neuromuscular disease or injury. Originally developed at MIT with Harvard Medical School, it works by reading the faint nerve signals from the surface of the skin then activating small motors to move the arm and hand as the user intends. The user is completely controlling their own hand and arm & the orthosis amplifies their weak muscle signal to help move the limb.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
316193
Start Date
April 05, 2019
Effective Date
April 05, 2019
Sponsor
Manufacturer
Country
United States of America
Address
137 Portland Street 4th Floor, Boston, MA, 02114