# K180773: Reusable and Self-Adhesive Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Shaoxing Dongzhi Electrical Technology Co., Ltd.
- Decided: May 22, 2018 after 60 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 K903402 (1990). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160081: TENS Electrodes, Cathay Manufacturing Corp. (2016) Summary page 4.

## Indications for use
This product is an adhesive electrode which is intended for use as the re-usable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. It is intended to be used with legally marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).

Source page: https://510kreport.com/device/K180773
Methodology: https://510kreport.com/methodology