Datasea Announces FDA Registration and Device Listing for NeuroVibe Acoustic BCI Biofeedback System as a Class II 510(k)-Exempt Biofeedback Medical Device

Datasea (NASDAQ: DTSS) announced that its variable interest entity Shuhai Jingwei (Shenzhen) has completed FDA establishment registration and device listing for the NeuroVibe Biofeedback System, including models NV-02 and NV-03.

Rhea-AI Summary

Datasea (NASDAQ: DTSS) announced that its variable interest entity Shuhai Jingwei (Shenzhen) has completed FDA establishment registration and device listing for the NeuroVibe Biofeedback System, including models NV-02 and NV-03. The devices are listed under FDA product code HCC as Class II 510(k)-exempt biofeedback medical devices in the Neurology category. According to Datasea, registration and listing do not represent FDA approval, clearance or authorization.

NeuroVibe is designed as a non-invasive acoustic brain-computer interface platform combining vibro-acoustic neuromodulation, EEG signal acquisition and AI-assisted health management to support brain health management, neurological function assessment, biofeedback training, stress reduction, sleep improvement and cognitive maintenance. Datasea views this listing as a key step in its international commercialization strategy and in building an acoustic AI-based brain health technology platform.

Positive

• FDA establishment registration and device listing completed for NeuroVibe NV-02 and NV-03 as Class II 510(k)-exempt biofeedback medical devices
• Defined U.S. regulatory pathway under product code HCC in Neurology supports potential commercial deployment and international strategy
• Non-invasive BCI platform integrates acoustic stimulation, EEG acquisition and AI-assisted health management for multiple brain health use scenarios

Negative

• FDA notes that establishment registration and device listing do not constitute approval, clearance or authorization of the NeuroVibe devices
• NeuroVibe is described as moving from R&D toward commercialization, indicating early-stage market adoption without disclosed revenue or adoption metrics

Argus Aug 11 session 8 alerts

+0.15% close to close 118.9x rel. volume Open Argus

Details

News Market Reaction – DTSS

-16.2% Trough in 1 hr 1 min

$8.84M Market Cap

On Aug 11, the day this news came out, DTSS closed 0.15% above the previous close. Argus tracked a trough of -16.2% from its starting point during tracking. Our momentum scanner recorded 8 alerts for this stock that day. Relative volume reached 118.9x the daily average during tracking.

Data tracked by StockTitan Argus for the Aug 11 session.

Market Context

Recent platform history recorded negative 24-hour reactions after the June 12 FDA-preparation update...

Analysis

Recent platform history recorded negative 24-hour reactions after the June 12 FDA-preparation update at -0.72% and the April 15 commercialization update at -3.6%. Low short positioning added limited short-interest risk context.

Key Figures

Device classification: Class II 510(k) status: 510(k)-exempt Technology modules: 4 core technology modules +1 more

Device classification

Class II

NeuroVibe biofeedback medical devices

510(k) status

510(k)-exempt

FDA-listed biofeedback medical devices

Technology modules

4 core technology modules

NeuroVibe platform architecture

Previously announced BCI systems

2 acoustic-driven BCI systems

Company strategic plan

Historical Context

5 past events · Latest: Jun 16

5 events

1. Jun 16

   Insider purchase plan

   24h Move

   -0.2%

   CEO announced a plan to purchase up to US$1.0 million of company shares

2. Jun 12

   FDA preparation update

   24h Move

   -0.7%

   Company advanced compliance work supporting potential FDA establishment registration and device listing

3. Apr 20

   AI project delivery

   24h Move

   -1.0%

   Three AI multimodal projects were delivered with aggregate contract value of approximately USD 1.01 million

4. Apr 15

   Commercialization update

   24h Move

   -3.6%

   Company advanced acoustic AI wellness robot commercialization and prepared U.S. product launch

5. Mar 24

   U.S. rollout update

   24h Move

   -1.2%

   Company announced initial U.S. commercial rollouts for acoustic technology-enabled wellness robots

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

510(k)-exempt, electroencephalogram (EEG), brain-computer interface, neuromodulation

4 terms

510(k)-exempt regulatory

"The products are listed under FDA product code HCC as Class II 510(k)-exempt"

510(k)-exempt indicates a category of medical devices that the U.S. Food and Drug Administration has determined does not require a premarket 510(k) notification before marketing because the devices are low-risk or well-understood. For investors, the designation matters because it is like selling a product that doesn’t need a building permit: companies can bring devices to market faster with lower upfront regulatory cost and delay, which affects revenue timing, development expense and regulatory risk.

electroencephalogram (EEG) medical

"electroencephalogram (EEG) signal acquisition, which collects and analyzes brainwave"

A noninvasive test that records the brain’s electrical activity using small sensors placed on the scalp, producing waveform patterns that reflect how brain cells are firing—think of it as a seismograph for electrical signals in the brain. Investors care because EEGs are widely used to diagnose and monitor neurological conditions, evaluate drug or device effects in clinical trials, and support regulatory and commercial decisions; changes in EEG results can influence trial outcomes, approvals, and market prospects.

brain-computer interface technical

"two acoustic-driven brain-computer interface (BCI) systems"

A brain-computer interface is a device or system that reads electrical signals from the brain and translates them into commands a computer or machine can understand, like a translator turning thoughts into actions. For investors, it matters because these technologies can create new markets in healthcare, assistive devices and consumer electronics, but they also carry high development costs, regulatory hurdles and uncertain adoption timelines that affect potential returns and risk.

neuromodulation medical

"transcranial vibro-acoustic stimulation, which enables non-invasive neuromodulation"

Neuromodulation is the use of devices or targeted treatments to change how nerves or brain circuits send signals, much like adjusting the volume or tuning on an audio system to alter what you hear. For investors, it matters because these therapies can treat chronic conditions (pain, movement disorders, depression) where existing medicines fall short, creating potential markets, regulatory milestones, and durable revenue streams if technologies prove safe and effective.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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BEIJING, Aug. 11, 2026 /PRNewswire/ -- Datasea Intelligent Technology Ltd. (NASDAQ: DTSS) ("Datasea" or the "Company"), a technology company focused on acoustic high-tech and AI multimodal digital solutions, today announced that Shuhai Jingwei (Shenzhen) Information Technology Co., Ltd. ("Shuhai Jingwei"), the Company's variable interest entity in China, has completed establishment registration and device listing with the U.S. Food and Drug Administration ("FDA") 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.

Innovative Vibro-Acoustic Neuromodulation Technology Provides a New Non-Pharmacological Pathway for Clinical Applications

The Company believes that Shuhai Jingwei's initiation of FDA establishment registration and device listing for NeuroVibe, and the products' listing as Class II 510(k)-exempt biofeedback medical devices, is one step forward from the research and development stage to a more clearly defined, regulated product platform with a potential for commercial deployment. It is a key step in translating technological value into clinical and market applications.

The initiation of NeuroVibe's device listing is an important step in Datasea's international commercialization strategy," said Zhixin Liu, Chief Executive Officer of Datasea. "NeuroVibe integrates acoustic intelligence, AI-assisted analysis and non-invasive brain-computer interface technology. We believe this milestone strengthens Datasea's positioning in next-generation brain health technology and it lays the foundation for product iteration, market validation and U.S. and global adoption."

Technology Architecture: A Non-Invasive Platform Combining Acoustic AI and Closed-Loop Biofeedback

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.

Differentiated Pathway: From Hardware Device to a Data- and Software-Enabled Brain Health Technology Platform

Datasea's differentiated strength lies in its acoustic AI technology pathway. 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 believes this structure may support the evolution of the product from a single hardware device toward a data- and software-enabled brain health technology platform.

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.

Commercialization Pathway: Focusing on Regulatory-Compliant Application Scenarios and Expanding Non-Pharmacological Intervention Pathways

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.

Company Outlook

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.

About Datasea Intelligent Technology Ltd. (NASDAQ: DTSS)

Datasea Intelligent Technology Ltd. is a Nasdaq-listed technology holding company focused on acoustic high-tech innovation and AI-powered multimodal digital solutions. The Company focuses on the development and commercialization of products, services, and solutions across acoustic high-tech and AI agent multimodal digitalization.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements involving risks and uncertainties, including but not limited to statements regarding the commercialization progress of the Company's products in target markets, compliance with regulatory obligations, market validation results, product iteration plans, channel development, application expansion and future business prospects. Actual results may differ materially from those expressed or implied by these forward-looking statements. Investors should not place undue reliance on these statements. Further information regarding risks and uncertainties is included in the Company's filings with the U.S. Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement except as required by applicable law.

Investor and Media Contact: 

Datasea Investor Relations
Email:  investorrelations@shuhaixinxi.com
            sunhezhi@shuhaixinxi.com

Precept Investor Relations LLC

David Rudnick
+1 646-694-8538
david.rudnick@preceptir.com

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SOURCE Datasea Intelligent Technology Ltd.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Datasea (NASDAQ: DTSS) announce about the NeuroVibe system on August 11, 2026?

Datasea announced that its NeuroVibe Biofeedback System, including NV-02 and NV-03, completed FDA establishment registration and device listing as Class II 510(k)-exempt biofeedback medical devices. According to Datasea, this marks progress from R&D toward a regulated platform with potential for commercial deployment.

Is Datasea’s NeuroVibe Biofeedback System FDA approved or cleared?

No, NeuroVibe is not FDA approved or cleared. The devices have FDA establishment registration and device listing only. According to Datasea, FDA specifically states that registration and listing do not constitute approval, clearance, or authorization of the establishment or the listed devices.

How is Datasea’s NeuroVibe Class II 510(k)-exempt device classified by the FDA?

NeuroVibe NV-02 and NV-03 are listed under FDA product code HCC as Class II 510(k)-exempt biofeedback medical devices in the Neurology regulatory area. According to Datasea, this classification guides regulatory-compliant application scenarios and frames the intended use for U.S. commercialization efforts.

What technology does Datasea’s NeuroVibe Acoustic BCI Biofeedback System use?

NeuroVibe uses non-invasive vibro-acoustic neuromodulation, EEG signal acquisition and AI-assisted health management in a closed-loop biofeedback platform. According to Datasea, it integrates acoustic stimulation, transcranial vibro-acoustic stimulation, real-time brainwave monitoring and intelligent analysis to support brain health and related wellness applications.

What are the potential application areas for Datasea’s NeuroVibe Class II biofeedback device?

Datasea expects U.S. commercialization to target brain health management, neurological function assessment, biofeedback training, stress relaxation, sleep improvement and cognitive maintenance. According to Datasea, these scenarios are intended to align with the product’s Class II 510(k)-exempt biofeedback classification and listed intended use.

How does the NeuroVibe listing fit Datasea’s international commercialization strategy for DTSS shareholders?

Datasea views NeuroVibe’s FDA device listing as an important step in its international commercialization strategy. According to Datasea, this milestone supports a pathway toward a scalable acoustic AI technology platform in brain health, intelligent interaction and the broader global health technology market.

What other acoustic brain-computer interface systems has Datasea disclosed besides NeuroVibe?

Datasea has disclosed an acoustic-coupled EEG signal enhancement system and a closed-loop vibration-enhanced BCI system. According to Datasea, these systems aim to enhance EEG signals, enable real-time vibration–neural feedback loops and support integration with intelligent health devices and rehabilitation-focused scenarios.