# K071661: Alphaone Biofeedback System

- Pathway: 510(k) (Traditional)
- Applicant: Telediagnostic Systems, Inc.
- Decided: Sep 5, 2007 after 78 days
- Product code: HCC (Device, Biofeedback)
- Device class: 2
- Regulation: 21 CFR 882.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The AlphaOne EEG biofeedback system is intended for use in relaxation training. In applications for relaxation training, the AlphaOne system provides visual and/or auditory signals that correlate with changes in EEG activity useful for achieving a state of relaxation. This device does not provide alarms and does not provide automated diagnostic analysis of EEG data, US Federal Law restricts this device to sale by, or on the order of, a licensed healthcare provider.

Source page: https://510kreport.com/device/K071661
Methodology: https://510kreport.com/methodology