Australia TGA ARTG record

Physical therapy electrical stimulation system, battery-powered

Australia TGA ARTG Registered Device · Darren Pereira · Shenzhen XFT Medical Limited · Class IIa · Started June 15, 2021

Good Name: Darren Pereira - Physical therapy electrical stimulation system, battery-powered

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: June 15, 2021
Effective Date: June 15, 2021

Sponsor

Name: Darren Pereira

Manufacturer

Name: Shenzhen XFT Medical Limited
Country: China
Address: Room 203 Building 1 Biomedicine Innovations Industrial Park #14 Jinhui Road, Pingshan New District, Shenzhen, 518122

Intended purpose

The H2 XFT-2003EA Hand Rehab System is an electronic device for rehabilitation training of patients who have suffered from upper limb dysfunction due to stroke or other causes of central nervous system injuries. The unit applies electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders of the upper limb. The H2 XFT-2003EA detects and monitors the EMG muscle activity signal of a patient and delivers mild electrical stimulation pulses according to EMG signal strength to stimulate the wearer in order to achieve a muscle contraction of upper limb muscles, primarily the forearm.

About this record

Access comprehensive regulatory information for Physical therapy electrical stimulation system, battery-powered 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 Shenzhen XFT Medical Limited in China. The device registration started on June 15, 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.