The following information is provided to those interested in the specific regulatory status of BrainMaster products relative to the US Food and Drug Administration (FDA).
Currently, the BrainMaster EEG products (2E, Atlantis, Discovery) are marketed in the U.S. under FDA (Food and Drug Administration) 510K 990538. This 510K was granted in May 19, 1999, and has remained current and in effect since then. BrainMaster has remained registered and in compliance with FDA-related requirements, and has passed all FDA inspections during that time. The original 510K was granted for the 2E, and the subsequent products, Atlantis and Discovery, were developed in compliance under that 510K, and are duly registered with the FDA as being covered by this 510K.
The classification cited in the 510K is “Biofeedback Device Electroencephalograph with an Electroencephalogram Signal Spectrum Analyzer and Biofeedback Options”
The 510K states that “The BrainMaster system will acquire EEG and biofeedback data, perform signal spectral analysis and qualification and provide auditory and/or visual feedback.”
The 510K also states that the devices “use EEG signals, measure EEG and process it to produce frequency band energy.”
The approved intended use is:
The BrainMaster equipment is indicated for relaxation training using alpha EEG Biofeedback. In the protocol for relaxation, BrainMaster provides a visual and/or auditory signal that corresponds to the patient’s increase in alpha activity as an indicator of achieving a state of relaxation.
The equipment is approved for Prescription Use, which means that is can be sold “to or on the order of a licensed practitioner.”
Any practitioner with biofeedback as part of their scope of practice can use BrainMaster equipment for this intended use.
The equipment can also, by virtue of its “spectral analysis and qualification” function, be used for initial assessments, including quantitative EEG (QEEG), for assessment in evaluations for which EEG biofeedback is being considered.
The Medical Device Register shows BrainMaster as Biofeedback (882.5050) as well as EEG (882.1400)
The online Product Classification includes 882.5050, Biofeedback Device, Neurology.
Sec. 882.5050 Biofeedback device.
(a) Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.
There is also a classification of 882.1400, Electroencephalograph applied to this device.
Sec. 882.1400 Electroencephalograph.
(a) Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
The 510K also refers to “spectral analysis of the EEG”
Therefore, a qualified practitioner could use this equipment for measuring the electrical activity of the patient’s brain, including “spectral analysis of the EEG.”
Software used to analyze EEG may also be used with the system, and that software should have its own 510K for its intended use, which should also include “spectral analysis of the EEG”
The Establishment Registration and Device Listing including 2E, Atlantis, and Discovery is at: