Datasea registers, lists NeuroVibe biofeedback system with FDA as Class II 510(k)-exempt device
DTSS•FDA registration and device listing
Datasea’s China VIE, Shuhai Jingwei, completed FDA establishment registration and device listing for its NeuroVibe Biofeedback System NV-02 and NV-03.
The devices were listed under product code HCC as Class II 510(k)-exempt biofeedback medical devices in the neurology area.
Registration and listing do not represent FDA clearance or approval for the devices.
