# K160081: TENS Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Cathay Manufacturing Corp.
- Decided: Oct 19, 2016 after 278 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: 4 generations back to K903402 (1990). 8 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080276: Self-Adhesive Electrodes, Cathay Health Care Equipment Manufacturing, Inc. (2008) Summary page 4.
- K132588: Adhesive Electrodes, Top-Rank Health Care Equipment Co., Ltd. (2013) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The proposed device is intended for use as the disposable, conductive adhesive interface between the patient’s skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with marketed electrical stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It’s for OTC use.

Source page: https://510kreport.com/device/K160081
Methodology: https://510kreport.com/methodology