(104 days)
EEG/Neurofeedback is indicated where general relaxation training is desired.
The Model A620-3 EEG biofeedback instrument is used by professionals for general relaxation training of patients.
Autogenics Model A620-3 EEG Biofeedback Instrument
I am sorry, but the provided text is a 510(k) clearance letter for the Autogenics Model A620-3 EEG Biofeedback Instrument. This document primarily focuses on the FDA's determination of substantial equivalence to a predicate device and administrative information. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in clinical study summaries or technical performance reports.
Therefore, I cannot provide the requested table and answers based on the given input.
§ 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.