ARTG 356651Physical therapy electrical stimulation system, battery-powered
ARTG ID: 356651 · DJO Global Pty Ltd · DJO LLC · Class IIa · Started March 12, 2021
Good Name: DJO Global Pty Ltd - Physical therapy electrical stimulation system, battery-powered
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 356651
- Start Date
- March 12, 2021
- Effective Date
- March 12, 2021
- Name
- DJO LLC
- Country
- United States of America
- Address
- 5919 Sea Otter Place, Suite 200, Carlsbad, California, 92010
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.
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 registered under ARTG number 356651 and 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.