# K163547: MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96

- Pathway: 510(k) (Traditional)
- Applicant: Neurovirtual USA, Inc.
- Decided: Apr 11, 2017 after 116 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K022197 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022197: Surface Electrode for Electroencephalography, The Electrode Store, Inc. (2002)
- K071118: Gold Cup Electrode, Silver Cup Electrode and Electrode with AG-AG/CL Coating and Conductive Plastic Electrode, Ives Eeg Solutions, Inc. (2007) Summary page 4.

## Indications for use
The MaxxiGold Electrode is intended for non-invasive use as recording electrodes in studies of physiological signals. These devices are indicated for use with adult or pediatric patients during electroencephalography, including biofeedback, sleep studies and evoked potential recordings.

Source page: https://510kreport.com/device/K163547
Methodology: https://510kreport.com/methodology