# K210448: Adhesive Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Shaoxing Yingtuo Healthcare Co., Ltd.
- Decided: Aug 31, 2021 after 196 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: 5 generations back to K903402 (1990). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160081: TENS Electrodes, Cathay Manufacturing Corp. (2016) Summary page 4.

## 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 stimulator, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).

Source page: https://510kreport.com/device/K210448
Methodology: https://510kreport.com/methodology