# K213879: Self-adhesive Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Bozhou Rongjian Medical Appliance Co., Ltd.
- Decided: Jan 5, 2022 after 23 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). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090198: Jiajian Self-Adhesive Electrode, Wuxi Jiajian Medical Instrument Co., Ltd. (2009) Summary page 5.

## Most influential descendants
- K252439: Tutamen Self Adhesive Electrodes (2026), 0 descendants of its own

## Indications for use
The Self-adhesive Electrode is intended to be used to transmit electrical stimulation current to the patient’s skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.

Source page: https://510kreport.com/device/K213879
Methodology: https://510kreport.com/methodology