Device Dossier

Physical therapy electrical stimulation system, battery-powered

Device Dossier for Physical therapy electrical stimulation system, battery-powered (Physical therapy electrical stimulation system, battery-powered,…

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.

TGA Public Summary