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. Announcement • Jun 14
Datasea Intelligent Technology Ltd. Advances Compliance Work and Related Procedures for U.S. Fda Establishment Registration and Device Listing for Its Acoustic Brain-Computer Interface Product Datasea Intelligent Technology Ltd. announced that the Company is advancing compliance work and related procedures required for U.S. Food and Drug Administration establishment registration and device listing for one of its acoustic brain-computer interface products. The Company has submitted its Dun & Bradstreet Data Universal Numbering System application, which is one of the administrative steps that support future FDA-related registration activities. The Company expects to continue evaluating and preparing for potential establishment registration, device listing and related regulatory procedures in accordance with applicable FDA requirements. These efforts represent an important preliminary step in the Company's international strategy for its acoustic medical and BCI-related product portfolio. The product is based on the Company's acoustic medical and BCI technology roadmap and integrates four core capabilities: acoustic stimulation, bone-conduction neuromodulation, EEG signal acquisition and AI-assisted health management. It is designed to focus on non-invasive acoustic neuromodulation-related application scenarios, with potential applications across neurological health fields, including brain health management, rehabilitation support, cognitive function monitoring, sleep quality optimization and emotional regulation. The Company believes that the integration of acoustic intervention, physiological signal monitoring and AI-based analysis provides a differentiated technical pathway compared with traditional invasive BCI approaches, and may offer potential advantages in safety profile, product accessibility, user compliance and future commercialization scalability. The Company has not obtained FDA clearance or approval for commercial distribution of the product in the United States. The Company will implement a systematic strategy to advance the preparatory compliance work required for U.S. FDA establishment registration and device listing, including the DUNS application, establishment registration documentation preparation, device listing documentation preparation, technical documentation preparation, product testing, regulatory communication and subsequent related procedures. The Company cautions that FDA-related procedures are subject to uncertainties relating to review timelines, regulatory requirements and review outcomes. The DUNS application, establishment registration or device listing does not by itself constitute FDA approval, clearance or authorization for commercial distribution of the relevant product. The Company will update investors and the market regarding material progress in accordance with applicable disclosure requirements. Announcement • Apr 18
Datasea Inc.(NasdaqCM:DTSS) dropped from NASDAQ Composite Index Datasea Inc. has been removed from NASDAQ Composite Index . 
