FDA-Device2024-09-04Class II
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.
RONAN MEDICAL LLC
Hazard
Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
Sold states
Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India.
Affected count
12
Manufactured in
3225 International Cir Ste 100, Colorado Springs, CO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2737-2024Don't want to check this manually?
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