(90 days)
NeuroComp is indicated for use in data acquisition and operant conditioning of the EEG. The device is to be used under the supervision of health professionals. This system is used for general relaxation.
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This document is a 510(k) clearance letter for a device called "NeuroComp." It primarily deals with regulatory approval and does not contain detailed information about acceptance criteria or specific studies demonstrating device performance. Therefore, I cannot provide the requested information.
The letter states that the device is "substantially equivalent" to previously marketed devices, meaning it meets regulatory requirements but not necessarily specific performance criteria outlined in a study in this particular document.
To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed technical specification for the NeuroComp device.
§ 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.