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EMU - Arm rehabilitation system - ARTG 475774

Access comprehensive regulatory information for EMU - Arm rehabilitation system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 475774 and sponsored by AIMedical International Pty Ltd, manufactured by Changsha Fourier Medical Technology Co Ltd in China. The device registration started on January 14, 2025.

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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Class IIa
ARTG 475774
Class IIa
EMU - Arm rehabilitation system
ARTG ID: 475774
Good Name: AIMedical International Pty Ltd - EMU - Arm rehabilitation system
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Intended Purpose

ArmMotus EMU is a 3D back-drivable upper limb rehabilitation equipment that adopted an innovative cable-driven mechanism, combined with a parallel linkage structure made of lightweight carbon fibre rods to reduce the friction and inertia of the device. This device allows the users to undergo different types of training modes, simulate a variety of daily life activities and induce the maximum active participation of the users through the provision of visual, auditory and tactile feedback to improve the rehabilitation effectiveness. According to the training parameters set by the operator, the PC will send out control instructions, and then the servo motor controls the position, speed, force, etc. of the handle according to the instructions issued by the PC and help the user's upper limb to carry out rehabilitation training. ArmMotus EMU is intended to enable individuals with upper limb impairments to improve muscle strength, ROM (Range of Motion), motor coordination, cognition and ADL (Activities of Daily Living). The ArmMotus EMU is not intended for aggressive use. At no time Fourier Intelligence claims that ArmMotus EMU will heal nor improve any patientโ€™s condition other than provide movement and exercise. Any treatment prescribed using the equipment should be done through a medical practitioner after he has fully tested and approved any of the equipment exercises.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
475774
Start Date
January 14, 2025
Effective Date
January 14, 2025
Manufacturer
Country
China
Address
No2 Room 204 2nd Floor Building 10 No579 Zhenhua Road, Yuhua, Changsha, 410000