ARTG 384016Free Walk Exoskeleton - Home Use Model - Ambulation exoskeleton, home-use
ARTG ID: 384016 · Darren Pereira · FREE Bionics Taiwan Inc · Class IIa · Started February 15, 2022
Good Name: Darren Pereira - Free Walk Exoskeleton - Home Use Model - Ambulation exoskeleton, home-use
- Risk Class
- Class IIa
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 384016
- Start Date
- February 15, 2022
- Effective Date
- February 15, 2022
- Name
- Darren Pereira
- Country
- Taiwan
- Address
- 5F-2 No 89 Dongmei Road East District, Hsinchu City, 30070
The Free Walk Exoskeleton (Home use 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 allow individuals to stand, rise from sitting to standing, walk 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. Users must first undergo training in the FreeWalk Exoskeleton therapy Model under professional guidance and supervision before a Free Walk home use model is recommended. Once a user has been deemed suitable for a FreeWalk Home Use model by their healthcare professional they will be competent and independent with the home use model.
Access comprehensive regulatory information for Free Walk Exoskeleton - Home Use Model - Ambulation exoskeleton, home-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 384016 and sponsored by Darren Pereira, manufactured by FREE Bionics Taiwan Inc in Taiwan. The device registration started on February 15, 2022.
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.