Device Dossier

Multi-modality physical therapy system

Device Dossier for Multi-modality physical therapy system (Multi-modality physical therapy system, Class IIa, sponsor AC Newco). ARTG record, intended…

Intended purpose

An active medical device for hyperthermia in the fields of dermatology or aesthetic medicine, and in sports medicine, rehabilitation and pain relief purposes. Physiotherapy, rehabilitation applications and sport medicine: The areas of application of RF therapy include osteoarticular and chronic diseases. It is therefore fundamental in cases of sprains, tendon injuries, bursitis tendinitis, results of bone and ligament trauma, acute and recurrent osteoarticular distractions and chronic arthralgias of various etiologies. Even in cases of osteoporosis and in post-surgical rehabilitation, this therapeutic modality brings significant benefits. Main therapeutic effects: muscle injuries, contractures, tendinitis, bursitis, lumbosciatica, focal treatment of the ipertono. Aesthetic medicine and dermatology applications: Neoelastogenesis and neocollagenesis, nonsurgical nonablative treatment of skin, wrinkle reduction, skin resurfacing. The capacitive mode acts specifically on the soft tissues (muscles, vascular/lymphatic system, etc). In resistive mode, the treatment involves exclusively the tissues with greater resistance (bone, cartilage, large tendons, aponeurosis).

TGA Public Summary