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510(k) Data Aggregation
K Number
K171414Device Name
qEEG-Pro
Manufacturer
Brainmaster Technologies, Inc.
Date Cleared
2018-07-01
(412 days)
Product Code
OLU
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
Brainmaster Technologies, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The qEEG-Pro System is to be used by qualified clinical professionals for the statistical evaluation of the human electroencephalogram (EEG).
Device Description
qEEG Pro Database (QPD) is a software program for the post-hoc statistical analysis of the human electroencephalogram (EEG). EEG recorded on a separate device (i.e., the host system) is transferred to the QPD for display and user-review. The device herein described consists of a set of tables that represent the reference means and standard deviations for representative samples. These tables are implemented as computer files that provide access to the exact tabular data resource for use by software that uses the tables as an information resource. The system requires that the user select reliable samples of artifact-free, eyes-closed or eyes open, resting digital EEG for purposes of analysis.
Analysis consists of the Fast-Fourier Transformation (FFT) of the data to extract the spectral power for each of the designated frequency bands (e.g. delta, theta, alpha, and beta), and frequency information from the EEG. The results of this analysis are then displayed in statistical tables and topographical brain maps of absolute and relative power, power asymmetry, and coherence for 19 monopolar and 171 selected bipolar derivations of the EEG. In all over 5,000 measures are derived for comparison against carefully constructed and statistically controlled age-regressed, normative database in which the variables have been transformed and validated for their Gaussian distribution.
Each variable extracted by the analysis is compared to the database using parametric statistical procedures that express the differences between the patient and an appropriate age-matched reference group in the form of z-scores.
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K Number
K150498Device Name
Discovery 24
Manufacturer
BRAINMASTER TECHNOLOGIES, INC.
Date Cleared
2016-01-26
(334 days)
Product Code
GWQ, GWO
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
BRAINMASTER TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for prescription use to acquire, record, transmit, and data for electroencephalograph studies of patients of all ages.
Device Description
The BrainMaster™ Discovery 24 are two-channel, four- channel, and 24-channel electrophysiological acquisition and biofeedback devices. The 24-channel (Discovery 24) digital EEG devices use industry-accepted Windowsbased PC as the control and display console. The devices consist of the following: BrainMaster™ Discovery 24 Hardware Module, BrainMaster™ software - BrainMaster™ BrainAvatar Acquisition software, Electrocap, which is sold separately. The system also includes a full set of DIN-compliant touch-proof sockets, either on the main housing, or in an accessory cable, that allows the use of "free sensors" without a cap. These products are designed for use with a standard IBM PC/AT compatible computers (Windows 7 and later) and associated peripheral equipment such as keyboard, mouse, and monitor(s). When assembled with a computer, the BrainMaster™ Discovery 24 system will acquire EEG and display and save it to disc.
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K Number
K990538Device Name
BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE
Manufacturer
BRAINMASTER
Date Cleared
1999-05-19
(89 days)
Product Code
HCC
Regulation Number
882.5050Why did this record match?
Applicant Name (Manufacturer) :
BRAINMASTER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BrainMaster™ 2E 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.
Device Description
This two-channel digital Biofeedback/EEG device uses industry-accepted standard Windows - based PC as control and display console. The device consists of the following:
- a) BrainMaster™ 2E Hardware Module
- BrainMaster™ BMT (basic educational/research SW) b)
- BrainMaster™ PT (clinical SW) c)
The System uses commercially available standard EEG electrodes and pastes such as 9 mm gold disks with 10 - 20 paste.
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