BrainCo Registers FocusXin ADHD Hardware and Software as Class II Devices
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.