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Orthosis, arm, elbow/wrist/hand, unit

Australia TGA ARTG Registered Device · Darren Pereira · Myomo Inc · Class I · Started April 05, 2019

Good Name: Darren Pereira - Orthosis, arm, elbow/wrist/hand, unit

Device classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration information
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
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.

About this record

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 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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