Pure Global

Free Walk Exoskeleton - Therapy Model - Ambulation exoskeleton, clinical

Access comprehensive regulatory information for Free Walk Exoskeleton - Therapy Model - Ambulation exoskeleton, clinical in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Darren Pereira, manufactured by FREE Bionics Taiwan Inc in Taiwan. The device registration started on September 07, 2021.

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 IIa
Class IIa
Free Walk Exoskeleton - Therapy Model - Ambulation exoskeleton, clinical
Australia TGA ARTG Registered Device
Good Name: Darren Pereira - Free Walk Exoskeleton - Therapy Model - Ambulation exoskeleton, clinical
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

The Free Walk Exoskeleton (Therapy Model) is battery powered bionic lower limb orthosis system designed to assist wearers with a walking disability regain lost motor function by manipulating the legs through a normal walking pattern during ambulation. The system includes a wearable exoskeleton structure that is used to train individuals in standing, rising from sitting to standing, walking and traversing various terrain. The control of the device is achieved through a user-operated wireless communicator built into a pair of forearm crutches, tilt sensor and specific body movements. It is intended for multiple- patient use in a controlled clinical setting such as a facility specialising in rehabilitation, under healthcare professional supervision.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
September 07, 2021
Effective Date
September 07, 2021
Sponsor
Manufacturer
Country
Taiwan
Address
5F-2 No 89 Dongmei Road East District, Hsinchu City, 30070