Device Dossier

Stimulator, electrical, analgesic, peripheral nerve, transcutaneous

Device Dossier for Stimulator, electrical, analgesic, peripheral nerve, transcutaneous (Analgesic TENS system, Class IIa, sponsor Actegy). ARTG record,…

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

TGA Public Summary