# K240668: Amydi-med Disposable Non-invasive EEG electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Amydi-Med Electrics Tech Co., Ltd.
- Decided: Mar 19, 2024 after 11 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: 8 generations back to K761301 (1977). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220448: Disposable Non-invasive EEG Sensor, Shenzhen Med-Link Electronics Tech Co., Ltd. (2023) Summary page 6.

## Indications for use
Amydi-med Disposable Non-invasive EEG Sensor is applied directly to an adults/pediatrics patient's skin to record physiological signals (e.g., the electroencephalogram, EEG) in the healthcare facility / hospital.

Source page: https://510kreport.com/device/K240668
Methodology: https://510kreport.com/methodology