# K132588: Adhesive Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Top-Rank Health Care Equipment Co., Ltd.
- Decided: Nov 22, 2013 after 95 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: 1 generation back to K070612 (2007). 1 ancestor in all.
6 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070612: Top-Rank Adhesive Electrode, Top-Rank Health Care Equipment Co., Ltd. (2007) Summary page 2.

## Most influential descendants
- K160081: TENS Electrodes (2016), 3 descendants of its own
- K210448: Adhesive Electrode (2021), 0 descendants of its own
- K180773: Reusable and Self-Adhesive Electrodes (2018), 0 descendants of its own
- K171722: Electrodes with snap / Electrodes with pigtail (2018), 0 descendants of its own
- K170744: Adhesive Electrodes (2017), 0 descendants of its own

## Indications for use
Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcuaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.

Source page: https://510kreport.com/device/K132588
Methodology: https://510kreport.com/methodology