Device Dossier

Multi-modality physical therapy system

Device Dossier for Multi-modality physical therapy system (Multi-modality physical therapy system, Class IIb, sponsor BTL Medical Technologies). ARTG…

Intended purpose

The intended purpose depends on the specific device configuration. Electrotherapy is a non-invasive therapeutic method based on electrical current flow through human tissues. The electric current is applied with the use of electrodes directly through patient’s skin. The use of electrotherapy is accepted in the field of rehabilitation for acute and chronic pain management, treatment of nerve and muscle tissue dysfunctions, treatment of post-traumatic joint mobility impairments, acute and chronic oedema reduction and peripheral blood flow increase. Ultrasound therapy is a non-invasive therapeutic method which uses mechanical energy of longitudinal waves penetrating deep through human soft-tissues resulting in local increase of blood flow and metabolism. The ultrasound therapy is mainly intended for treatment of muscle and connective tissue disorders, reduction of post-traumatic conditions as oedema and healing process acceleration. Low-level laser therapy is a non-invasive therapeutic method based on application of coherent, polarized, monochromatic light in a form of laser beam. The laser beam is absorbed in human tissues and its energy is transmitted to the tissue cells to help restore their normal function. The effect is above all bio-stimulating, regenerating, anti-inflammatory and analgesic, based on the induced photochemical reactions. Low-level laser is useful in the therapy of painful disorders of the musculoskeletal system, in the therapy of inflammatory conditions of skin, mucosa and soft-tissue and in accelerated healing of wounds (e.g. burns, scars) and soft-tissue injuries.

TGA Public Summary