BrainMaster US FDA Registration Information #
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 for biofeedback 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.
The Discovery is also registered as a clinical EEG device, for neurological use, as described below with links to our registrations.
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)
http://www.medicregister.com/Brainmaster_Technologies/Supplier/sid19108.htm
The online Product Classification includes 882.5050, Biofeedback Device, Neurology.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=3408
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=882.5050
| 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.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRsearch.cfm?FR=882.1400
In summary, we have been registered with the FDA for biofeedback since 1999, going on 20 years. The indications for use include relaxation and self-regulation, and any licensed practitioner may use or supervise the use of our systems within their scope of practice. This covers all of our devices and systems, 2E, 2EW, 2EB, Atlantis, Discovery, and we are in the process of registering the Freedom. For the past 20 years, we have been audited and approved for this use by both the FDA an also the ISO (International Standards Organization) for international, particularly European, sales. Other devices in our world typically have this registration, although some do not. Biofeedback practitioners should look for and insist on this registration. The “predicate” devices for this registration are the original Lexicor and Autogenics devices, which are EEG biofeedback devices.
“Indicated for relaxation training using alpha EEG biofeedback”
Ours is online at:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K990538
In 2016, we acquired an additional registration, for the Discovery, as a clinical EEG. This is a much more stringent registration to get, and requires additional examination and testing. The Discovery was found to hold to the highest quality of technical specification, performance, and reliability, to earn this registration. Under this registration, Discovery can be used by neurologists and other EEG professionals for clinical EEG, and will stand up in insurance or medicolegal matters, as a full clinical EEG. The “predicate” device for this registration is the Vangard system that I led the design of at the Cleveland Clinic, which is a full-head clinical EEG.
“Indicated for prescription use to acquire, record, transmit, and display physiological and data for electroencephalograph
studies of patients of all ages.”
The registration is online at:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K150498
We are the only U.S. supplier with both of these registrations. That means that practitioners of all types, including biofeedback therapists, and neurologists and other health care professionals, can use our equipment with the confidence that it meets all regulatory and technical requirements for biofeedback, and that the Discovery is further registered as a clinical EEG.
In addition to these two 510K registrations, we also have registered the MicroTesla as an electromagnetic therapeutic device.
Our establishment registration is at:
We are proud of the work we have put into this engineering and registration, resulting in high quality products, that meet the highest standards of the professional and regulatory communities.
| 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:
All images, information, concepts, and examples are property of Brainmaster Technologies, Inc. and are not to be duplicated or transferred with out expressed written permission of BrainMaster Technologies, Inc. Atlantis I, MicroTesla, BrainAvatar are all trademarks of BrainMaster Technologies. Equipment sold only under the supervision of a licensed practitioner only to be used within scope of practice for relaxation purposes using Alpha waves. Registered as MicroTesla Therapeutic Magnetic Stimulator for pain control. Patent pending on BrainAvatar and Live Z-Score software. All Brainmaster equipment meets IEC-60601, ISO, AAMI, FDA, and CE standards.
