# K012011: Modification to A620 Eeg

- Pathway: 510(k) (Special)
- Applicant: Stoelting Co.
- Decided: Oct 10, 2001 after 104 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
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.

Source page: https://510kreport.com/device/K012011
Methodology: https://510kreport.com/methodology