# K171381: Adhesive Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Quality Medical Technology Co.,Ltd
- Decided: Dec 13, 2017 after 216 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 K903402 (1990). 17 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132998: Wandy Self-Adhesive Electrodes, Wandy Rubber Industrial Co., Ltd. (2013) Summary page 5.
- K160138: Adhesive Electrodes, Gmdasz Manufacturing Co., Ltd. (2016) Summary page 5.

## Most influential descendants
- K190700: Electrodes Pad (2019), 1 descendant of its own
- K221589: Starly pad (2023), 0 descendants of its own

## Indications for use
The Adhesive Electrodes are intended to transmit electrical current to patient skin for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation) applications. It is for OTC (Over-The-Counter) or Prescription use and is to be used for adults only.

Source page: https://510kreport.com/device/K171381
Methodology: https://510kreport.com/methodology