# K173186: S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D

- Pathway: 510(k) (Special)
- Applicant: Everyway Medical Instruments Co.,Ltd
- Decided: Feb 28, 2018 after 149 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
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
The S Series Electrodes (including S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D) are intended for use with transcutaneous neurostimulation devices as over the counter. Some common type of neurostimulation devices include, but are not limited to, TENS devices and EMS devices. Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a patient’s skin and a neurostimulation device.

Source page: https://510kreport.com/device/K173186
Methodology: https://510kreport.com/methodology