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

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

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.