# K181234: Self-adhesive Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Dong Guan OU Kang Electronics Co., Ltd.
- Decided: Aug 7, 2018 after 90 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: 7 generations back to K945676 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152815: Mailuokang Self-adhesive Electrode, Shenzhen Mailuokang Technology Co., Ltd. (2016) Summary page 4.

## Indications for use
Self-adhesive electrode is intended for single use, conductive adhesive interface between the patient’s skin and the electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use, for single patient use only.

Source page: https://510kreport.com/device/K181234
Methodology: https://510kreport.com/methodology