Datasea Announces FDA Registration and Device Listing for NeuroVibe Acoustic BCI Biofeedback System as a Class II 510(k)-Exempt Biofeedback Medical Device
Datasea announced that its NeuroVibe Acoustic BCI Biofeedback System received FDA registration and device listing as a Class II 510(k)-exempt biofeedback medical device.
Why it matters — This registration allows Datasea to market its NeuroVibe system as a medical device in the U.S., marking a regulatory milestone for the company's acoustic BCI technology.