Announcement • Aug 13

Shuhai Jingwei (Shenzhen) Information Technology Co., Ltd. Completes FDA Registration and Device Listing for Neurovibe Biofeedback System as Class Ii 510(K)-Exempt Biofeedback Medical Device

Shuhai Jingwei (Shenzhen) Information Technology Co. Ltd. has completed establishment registration and device listing with the U.S. Food and Drug Administration for its NeuroVibe Biofeedback System, including products NV-02 and NV-03. The products are listed under FDA product code HCC as Class II 510(k)-exempt biofeedback medical devices within the Neurology regulatory area. FDA establishment registration and device listing do not constitute FDA approval, clearance or authorization of the establishment or the listed devices. NeuroVibe is designed as a non-invasive biofeedback platform integrating four core technology modules: (1) acoustic stimulation, which uses acoustic input at specific frequencies to modulate neural states; (2) tricuspid valve annulus size (tVAS) neuromodulation, or transcranial vibro-acoustic stimulation, which enables non-invasive neuromodulation; (3) electroencephalogram (EEG) signal acquisition, which collects and analyzes brainwave physiological signals in real time; and (4) AI-assisted health management, which provides intelligent analysis and feedback optimization based on individual patient data. Through this architecture, the system is able to collect and analyze human physiological signals and provide real-time biofeedback to support neurological function assessment and training, brain health management and related wellness-oriented applications. NeuroVibe is not designed merely as an EEG data acquisition device. Rather, it is intended to integrate acoustic physical input, neural signal acquisition, AI-driven analysis and feedback mechanisms into a closed-loop system. The Company has previously announced two acoustic-driven brain-computer interface (BCI) systems that support its strategic plan to develop innovative medical technology. The first is an acoustic-coupled EEG signal enhancement system, which is designed to enhance EEG signal quality through acoustic physical fields. The second is a closed-loop vibration-enhanced BCI system, which is designed to enable a real-time closed loop between vibration stimulation and neural feedback. These systems are intended to support signal enhancement, individualized feature extraction, feedback regulation and potential integration with intelligent health devices and rehabilitation-support scenarios. Datasea expects that NeuroVibe's early commercialization efforts in the U.S. market will focus on regulatory-compliant application scenarios aligned with the product classification and intended use listed. Potential application areas include brain health management, supporting neurological function assessment and dynamic tracking; biofeedback training, enabling real-time visualization of physiological signals and self-regulation; stress relaxation, through vibro-acoustic coupling to modulate the autonomic nervous system; sleep improvement, through closed-loop intervention based on brainwave rhythms; and, cognitive maintenance, including support for attention, memory and other cognitive functions. The Company believes that with the growing demand for non-pharmacological and non-invasive health technologies, NeuroVibe's technology pathway represents immense potential for the expansion of its medtech product applications. Datasea believes that Shuhai Jingwei's initiation of NeuroVibe's listing as Class II 510(k)-exempt biofeedback medical devices further strengthens the Company's strategic positioning in acoustic intelligence, AI-driven health technology and non-invasive neurotechnology. The Company plans to continue advancing product iteration, regulatory compliance, channel development and application validation with the goal of building a scalable acoustic AI technology platform for brain health, intelligent interaction and the global health technology market.

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Shuhai Jingwei (Shenzhen) Information Technology Co., Ltd. Completes FDA Registration and Device Listing for Neurovibe Biofeedback System as Class Ii 510(K)-Exempt Biofeedback Medical Device

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