Device Dossier
Gymna Acure - Stimulator, electrical, neuromuscular, diagnostic
Device Dossier for Gymna Acure - Stimulator, electrical, neuromuscular, diagnostic (Stimulator, electrical, neuromuscular, diagnostic, Class IIa, sponsor…
- GMDN category: Stimulator, electrical, neuromuscular, diagnostic
Intended purpose
The Gymna Acure device series is intended for the application of ultrasound guided electrolysis, an innovative application technique in the field of electrotherapy. A galvanic current is applied to the patient by the use of an acupuncture needle electrode, functioning as the cathode (negative electrode) in the electrical circuit. For the anode (positive electrode), a large-size rectangular-shaped silicone-rubber electrode is used, together with a well-moistened sponge making direct contact to the skin surface. It is important that the silicone-rubber electrode and well-moistened sponge are placed at short distance with respect to the pathological area which is to be treated. Making use of the fixation strap allows for short interpolar distances, independently of the treatment location. The needle puncture must be inserted under echography guidance in order to apply the current exclusively to the degenerated/damaged tissue. The application produces an electrochemical reaction (electrolysis) in the treated area and initiates a local inflammatory response necessary for tissue regeneration, leading to tissue recovery. Galvanic Electrolysis is a possible therapy technique intended for patients (age 18 and up) suffering from: • Chronical tendinopathies • Soft tissue injuries • Trigger point tension The intended users are physiotherapists and acupuncturists certified to perform electrolysis and dry needling and medical doctors. They must have the legal authorisation to perform this treatment in the country where they practice their profession.