# K191975: Elefix V Paste for EEG & EMG

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Corporation
- Decided: Feb 7, 2020 after 198 days
- Product code: GYB (Media, Electroconductive)
- Device class: 2
- Regulation: 21 CFR 882.1275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K860210 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860210: Elefix Electrode Cream, Nihon Kohden America, Inc. (1986) Summary page 5.

## Indications for use
Elefix V Paste for EEG & EMG is a conductive paste used with surface electrodes to lower skin-electrode impedance. It can be used with electrodes for EEG and EMG examination.

Source page: https://510kreport.com/device/K191975
Methodology: https://510kreport.com/methodology