# K152815: Mailuokang Self-adhesive Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mailuokang Technology Co., Ltd.
- Decided: Mar 8, 2016 after 162 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: 6 generations back to K945676 (1995). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112312: Theratrode, Phoenix Medical Devices, Llp (2012) Summary page 5.

## Most influential descendants
- K181234: Self-adhesive Electrode (2018), 0 descendants of its own

## Indications for use
Mailuokang Self-adhesive Electrode is intended for use as reusable, conductive adhesive interface between the patient’s skin and the electrical stimulation devices. Example electrical stimulation devices for current applications of the electrodes includes, but are not limited to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation). Mailuokang Self-adhesive Electrode is for prescription use and over-the-counter use, for single patient use only.

Source page: https://510kreport.com/device/K152815
Methodology: https://510kreport.com/methodology