# K170744: Adhesive Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Reno Medical, Ltd.
- Decided: May 8, 2017 after 59 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: 2 generations back to K070612 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132588: Adhesive Electrodes, Top-Rank Health Care Equipment Co., Ltd. (2013) Summary page 5.

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

Source page: https://510kreport.com/device/K170744
Methodology: https://510kreport.com/methodology