Pure Global

Physical therapy electrical stimulation system, battery-powered

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 DJO Global Pty Ltd, manufactured by DJO LLC in United States of America. The device registration started on March 12, 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.

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TGA ARTG Official Data
Class IIa
Class IIa
Physical therapy electrical stimulation system, battery-powered
Australia TGA ARTG Registered Device
Good Name: DJO Global Pty Ltd - Physical therapy electrical stimulation system, battery-powered
Pure Global
DJ Fang

DJ Fang

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Intended Purpose

As an neuromuscular electrical nerve stimulation (NMES) device, indications are for the following conditions: • Retarding or preventing disuse atrophy, • Maintaining or increasing range of motion, • Re-educating muscles, • Relaxation of muscle spasms, • Increasing local blood circulation, and • Prevention of venous thrombosis of the calf muscles immediately after surgery. As a transcutaneous electrical stimulation (TENS) device, indications are for the following conditions: • Symptomatic relief and management of chronic, intractable pain, • Adjunctive treatment for post-surgical and post-trauma acute pain, and • Relief of pain associated with arthritis. As an functional electrical stimulation (FES) device, the indications for the following condition: • Stimulation of the leg and ankle muscles of partially paralyzed patients to provide flexation of the foot, thus improving the patient's GAIT.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 12, 2021
Effective Date
March 12, 2021
Manufacturer
Country
United States of America
Address
5919 Sea Otter Place, Suite 200, Carlsbad, California, 92010