Device Dossier
Stimulator, electrical, analgesic, peripheral nerve, transcutaneous
Device Dossier for Stimulator, electrical, analgesic, peripheral nerve, transcutaneous (Analgesic TENS system, Class IIa, sponsor Bioelectro). ARTG…
- GMDN category: Analgesic TENS system
Intended purpose
Non-invasive, electrotherapeutic, hand-held device that can be used to reduce acute and chronic pain, improve blood circulation, perform passive muscle stimulation, and facilitate functional restoration and improvement. The device uses the process of non-invasive neuro-stimulation. The device is applied to intact skin. Direct application on injured skin is not advised. The recommend treatment duration for the device ranges from a few minutes to a maximum of 1 hour. The treatment is usually performed by moving the device on the skin. The field of application is primarily in trained, professional therapy, but also extends to trained private users.