Datasea Intelligent Technology Ltd. (NASDAQ: DTSS) announced that its China-based variable interest entity, Shuhai Jingwei (Shenzhen) Information Technology Co., has completed establishment registration and device listing with the U.S. Food and Drug Administration for its NeuroVibe Biofeedback System, covering products NV-02 and NV-03.

The devices are listed under FDA product code HCC as Class II 510(k)-exempt biofeedback medical devices within the neurology regulatory area. The company noted that FDA establishment registration and device listing do not constitute FDA approval, clearance, or authorization of the establishment or the listed devices.

NeuroVibe is described as a non-invasive biofeedback platform combining four technology components: acoustic stimulation, transcranial vibro-acoustic stimulation, electroencephalogram signal acquisition, and AI-assisted health management. The system is designed to collect and analyze physiological signals and provide real-time biofeedback for neurological function assessment and brain health applications.

Datasea Chief Executive Officer Zhixin Liu said in a statement that "the initiation of NeuroVibe's device listing is an important step in Datasea's international commercialization strategy," adding that the company believes the milestone "lays the foundation for product iteration, market validation and U.S. and global adoption."

According to the company, early U.S. commercialization efforts will focus on application areas including brain health management, biofeedback training, stress relaxation, sleep improvement, and cognitive maintenance, consistent with the product's listed classification and intended use.

Datasea said it plans to continue product development, regulatory compliance work, and channel development as part of a broader strategy to build what it describes as a scalable acoustic AI technology platform.