(185 days)
BioLex is indicated for relaxation training using alpha EEG biofeedback. In the protocol for relaxation training, BioLex 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 NRS-2D is a two channel electrophysiological signal acquisition and biofeedback device. The product is designed for use with a standard IBM PC/AT compatible computer and associated peripheral equipment. When assembled with the computer, the NRS-2D system will acquire EEG and biofeedback data, perform signal spectral analysis and quantification and provide auditory and/or visual feedback. At the user's discretion the NRS-2D can be factory configured as a single channel device.
The provided text describes the Lexicor NRS-2D, a two-channel electrophysiological signal acquisition and biofeedback device. It focuses on device specifications and intended use but does not contain information about acceptance criteria or specific studies proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
The document primarily covers:
- Device Description: The NRS-2D is a two-channel device for acquiring EEG and biofeedback data, performing signal spectral analysis, and providing auditory/visual feedback. It can also be configured as a single-channel device.
- Intended Use: For relaxation training using alpha EEG biofeedback, providing visual and/or auditory signals corresponding to increased alpha activity.
- Warnings and Contraindications: Patients unwilling or unable to understand feedback principles, those experiencing anxiety from EEG biofeedback, and a warning regarding potential causal relationship between EEG training and seizures in epilepsy.
- Technological Characteristics: Details about the acquisition and preprocessing unit, including filters (lowpass, highpass, notch), A/D converter, microprocessor control, and communication with a PC. Specifications like sampling rate (128Hz), gain (8,000), and electrode continuity checking are mentioned.
- Device Specifications Table: A table outlining physical dimensions, signal acquisition parameters (channels, sampling rate, frequency resolution, noise, notch filtering, CMRR, gain, filters, input impedance, A/D resolution), and power details (AC power, battery power).
§ 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.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.