# K113375: Eswallow Usa Electrode,Eswallow Usa Leadwire

- Pathway: 510(k) (Traditional)
- Applicant: Eswallow USA
- Decided: Jan 25, 2013 after 436 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: 5 generations back to K871222 (1987). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083756: Guardian 150 Electrode, Selectivemed Components, Inc. (2009) Summary page 2.

## Indications for use
For muscle reeducation by application of external stimulation to the muscles necessary for pharyngeal contraction.

Source page: https://510kreport.com/device/K113375
Methodology: https://510kreport.com/methodology