PRESS RELEASE EVENTS & PRESENTATIONS IR DOCUMENTS
Products

Acoustic Healthcare & NeuroVibe

Product and service applications across air health, sleep health, foot health, head and personal care — and Datasea’s first-generation acoustic-medical product platform.

Part 01

Acoustic Healthcare

Datasea’s acoustic-healthcare activities include product and service applications in air health, sleep health, foot health, head and personal care. These applications combine acoustic technologies with sensing, device control and software-enabled service capabilities, with product-specific configurations for different use scenarios.

Datasea acoustic air-health device in a living-room setting

Air Health

Acoustic air-care products combining ultrasound, sensing and device control.

Datasea acoustic sleep-health device on a bedside table

Sleep Health

Acoustic sleep-aid products with sound delivery and software services.

Datasea smart air sterilizer in white and black panel designs

Smart Air Sterilizer

Sound waves remove bacteria and odors to create a healthy, hygienic and high quality living environment

Datasea acoustic head and personal-care device

Head & Personal Care

Head and personal-care applications with product-specific configurations.

Part 02

NeuroVibe Biofeedback System

NeuroVibe is Datasea’s first-generation acoustic-medical product platform developed around acoustic intelligence, non-invasive biofeedback and brain-computer-interface technologies. Depending on the model and configuration, NeuroVibe may integrate physiological or EEG-related signal acquisition, acoustic or vibroacoustic stimulation, signal processing, AI-assisted analysis, feedback functions and personalized parameter adjustment.

NeuroVibe NV-02 acoustic biofeedback headband device
NeuroVibe Technology Modules Technology modules only — no disease-treatment claims
1
EEG / physiological signal acquisitionPhysiological or EEG-related signal collection, by model and configuration
2
Acoustic / vibroacoustic stimulationAcoustic or vibroacoustic stimulation modules
3
Signal processingFeature extraction and conditioning of collected signals
4
AI-assisted analysisAssisted analysis of processed signals
5
Feedback functions & personalized parameter adjustmentWithin customer-authorized parameters
Regulatory Status

U.S. FDA Establishment Registration & Device Listing

NeuroVibe NV-02 NeuroVibe NV-03 Product code: HCC Class II 21 CFR 882.5050 — “Biofeedback Device” 510(k)-exempt

Following the end of FY2026, the relevant operating entity completed U.S. FDA establishment registration and device listing for the NeuroVibe NV-02 and NV-03 models. Based on currently available FDA registration information, the listed devices are associated with product code HCC, are classified as Class II devices and fall under 21 CFR 882.5050, “Biofeedback Device.”

Regulatory Note

FDA establishment registration, device listing and a 510(k)-exempt classification do not constitute FDA approval, clearance, certification or endorsement and do not establish effectiveness for any particular disease or therapeutic use. Marketing, labeling, distribution and use in the United States remain subject to applicable FDA requirements.