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2026-01-05 00:00 China Policy & Regulation Regulatory Approval Translated from EN

BrainCo Registers FocusXin ADHD Hardware and Software as Class II Devices

Summary BrainCo's FocusXin Medical Edition combines a single-channel prefrontal EEG device registered as 浙械注准20232071898 with ADHD rehabilitation software registered as 浙械注准20252211934. The Class II system is intended for supplementary rehabilitation training in children aged 6 to 12 with ADHD. Its defined medical use should not be generalized into approval for an unspecified consumer BCI product.
Why it matters Separate registrations for the hardware and software define a narrow pediatric ADHD rehabilitation use and draw a regulatory line between the medical edition and general attention-training products.
BCIwiki (bciwiki.com) — BrainCo’s FocusXin Medical Edition combines a single-channel prefrontal EEG acquisition device with ADHD rehabilitation software, both registered as Class II medical devices in Zhejiang province in eastern China. The hardware registration is 浙械注准20232071898 and the software registration is 浙械注准20252211934.

The software is designed to work with the EEG device and provides relaxation, neurofeedback and cognitive training. Its registered use is supplementary rehabilitation training for children aged 6 to 12 with ADHD, with guardian supervision recommended. BrainCo’s product page also lists contraindications, precautions and medical-device use notices.

The registrations cover this defined medical hardware-and-software package. They do not amount to broad approval for an unspecified consumer BCI product, nor do they establish effectiveness for every child or every attention-related condition.

Compiled by BCIwiki from public sources

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