Pure Global

Anti-tremor gyroscopic orthotic glove - ARTG 427773

Access comprehensive regulatory information for Anti-tremor gyroscopic orthotic glove in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 427773 and sponsored by C R Kennedy & Co Pty Ltd, manufactured by GyroGear Ltd in United Kingdom. The device registration started on November 13, 2023.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
ARTG 427773
Class I
Anti-tremor gyroscopic orthotic glove
ARTG ID: 427773
Good Name: C R Kennedy & Co Pty Ltd - Anti-tremor gyroscopic orthotic glove
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

A battery-powered device designed to be worn on the hand/forearm of a patient with hand tremors [e.g., due to Parkinsonโ€™s disease, Essential tremor (ET)] to reduce tremors and facilitate activities of daily living using the hand. It is in the form of a glove with forearm sleeve and built-in gyroscopes which generate tremor-countering forces to promote hand stabilization.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
427773
Start Date
November 13, 2023
Effective Date
November 13, 2023
Manufacturer
Country
United Kingdom
Address
90A High Street Berkhamsted, Hertfordshire, HP4 2BL