Device Dossier
Biofeedback system
Device Dossier for Biofeedback system (Biofeedback system, Class IIa, sponsor Brain Mind & Memory Institute). ARTG record, intended purpose, GMDN…
- GMDN category: Biofeedback system
Intended purpose
The EEG Neuroamp is intended for biofeedback and relaxation purposes. To perform its intended function it must be used in combination with a computer and appropriate software. For purposes of this training task, information for feedback may be derived from one or two channels of EEG and from as many as three channels of peripheral physiology measures such as are conventionally used in biofeedback. The EEG NeuroAmp is intended to be used in the office by trained professionals who can ensure sound handling practices. The EEG NeuroAmp is not intended for diagnostic purposes.