Device Dossier

Analgesic TENS system

Device Dossier for Analgesic TENS system (Analgesic TENS system, Class IIa, sponsor Actegy). ARTG record, intended purpose, GMDN category — compiled by…

Intended purpose

Revitive device delivers Electrical Muscle Stimulation (EMS) to your feet and may: • Reduce pain and discomfort in the in the leg, foot and ankle caused by poor • circulation (Peripheral Arterial Disease) • Improve circulation in the legs caused by Peripheral Arterial Disease • Improve circulation to reduce or prevent blood-pooling (stasis) - caused by poor • circulation (Chronic Venous Insufficiency/Varicose Veins • Increase walking distance before the onset of claudication symptoms (pain) – • caused by Peripheral Arterial Disease • Improve symptoms associated with varicose veins/ Chronic Venous Insufficiency • Reduce swelling in the knee caused by osteoarthritis • Reduce swelling volume and discomfort in the lower leg, foot and ankle due to • prolonged inactivity and/or a sedentary lifestyle, in healthy individuals. • Reduce swelling in the ankle following acute ankle injury • Improve circulation in the legs caused by being immobile following lower limb • surgery • Support and improve blood circulation, due to prolonged inactivity and/or a • sedentary lifestyle, in healthy individuals • Reduce pain and discomfort in the legs caused by diabetic peripheral neuropathy • Reduce pain and discomfort associated with knee osteoarthritis • Reduce pain and discomfort in the legs following knee surgery • Increase muscle strength in the legs of people with knee osteoarthritis • Increase muscle strength in the legs of people affected by COPD • Increase muscle strength in the legs of patients following lower limb surgery When using REVITIVE to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide: • Temporary relief of lower back pain • Relief of chronic elbow or shoulder pain caused by injury or overuse • Relief of chronic pain in the knee caused by osteoarthritis • Relief of chronic neuropathic pain • Temporary relief of post-surgical pain in the knee

TGA Public Summary