Device product
BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to the status of a patients physiological parameters so that the patient can control voluntarily these physiological parameters.
Z-2737-2024
Product summary
- Event
- Event 95089
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12
- Official record key
device-enforcement:Z-2737-2024
Official wording
Reason: Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
Code information: UDI-DI: 08592566001017, 08592566001123, Serial Numbers: ACBFB12-1911003, ACBFB12-2004012, ACBFB12-2004014, ACBFB12-2105001, ACBFB12-2105002, ACBFB12-2105004, ACBFB12-2105005, ACBFB12-2109005, ACBFB12-2109006, ACBFB12-2109007, ACBFB12-2109008, ACBFB12-2301024
Distribution pattern: Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India.
Derived failure modes
-
Unknown
Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.