Datasea Intelligent Technology Ltd., together with its subsidiaries, provides advanced acoustic products and solutions to businesses and individual users worldwide. It operates through Acoustic High-Tech and AI Multimodal Digitalization segment. The company offers smart city solutions for residential communities, schools, and commercial enterprises; and 5G messaging services, including 5G SMS, 5G MMCP, and 5G multi-media video messaging. It also provides its smart security solutions primarily to schools, tourist or scenic attractions, and public communities. In addition, the company offers acoustics health products, which include ultrasonic air sterilizers, ultrasonic cleaning devices, non-contact sleep aid devices, and medical beauty devices; ultrasonic disinfectors and purifiers for restrooms, bedrooms, living rooms, kitchens, and pets; and non-contact ultrasonic skin repair devices. Further, it provides digital rural, new media marketing, and AI multimodal services for small and medium enterprises. It sells its products through multi-channels. The company was formerly known as Datasea Inc. and changed its name to Datasea Intelligent Technology Ltd. in April 2026. Datasea Intelligent Technology Ltd. was incorporated in 2014 and is headquartered in Beijing, the People's Republic of China.
Datasea Announces FDA Registration and Device Listing for NeuroVibe Acoustic BCI Biofeedback System as a Class II 510(k)-Exempt Biofeedback Medical Device
Datasea's VIE, Shuhai Jingwei, completed FDA establishment registration and device listing for its NeuroVibe Biofeedback System (NV-02, NV-03) as Class II 510(k)-exempt devices.
This milestone advances the product from research to a regulated commercial platform, though the company clarified the listing does not constitute official FDA approval or clearance.
Management highlighted the step as critical for international commercialization, targeting applications in brain health, stress relaxation, and cognitive maintenance.