# K223628: NEBA® Compact EEG2R Mobile Headset

- Pathway: 510(k) (Traditional)
- Applicant: Neba Health, LLC
- Decided: Mar 2, 2023 after 87 days
- Product code: OMC (Reduced- Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K830295 (1983). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203827: REMI, Epitel, Inc. (2021) Summary page 4.
- K183529: AE-120A EEG Head Set, Nihon Kohden Corporation (2019) Summary page 4.

## Indications for use
The NEBA® Compact EEG 2R Mobile Headset (NEBA Headset) is intended to capture, amplify, and wirelessly transmit electrical brain activity for review by a trained medical professional using the CEEG2R recording software. The NEBA Headset comprises an electrode positioning system for placing single-use disposable electrodes on the head (Vermed® A10005, ANSI/AAMI EC12 compliant silver/silver-chloride (Ag/AgCl) electrodes). Contained within the headset is a wireless EEG amplifier module. The NEBA Headset and its associated software do not provide any diagnostic conclusion or automated alerts of any clinical event about a patient's condition. The NEBA Headset transmits electrophysiological signals from the electrodes to a CEEG 2R IEC/UL 60950-1 safety compliant computer running the NEBA CEEG 2R recording software. The system supports six electrode locations (CZ, left ocular, right ocular, left ear, right ear, and ground) on four flat flexible leads and one plastic tab (the latter to support the CZ electrode). The CEEG2 Headset is intended for use in clinical settings in individuals six years of age and older.

Source page: https://510kreport.com/device/K223628
Methodology: https://510kreport.com/methodology