# K222453: Self-adhesive Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Comytens Medical Technology Co., Ltd.
- Decided: Nov 4, 2022 after 81 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: 8 generations back to K903402 (1990). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180865: ZMI Self-Adhesive Electrodes, Zmi Electronics, Ltd. (2018) Summary page 5.

## Indications for use
Self-Adhesive Electrode is intended for as a reusable, conductive adhesive interface between the patient’s skin and the marketed electrical stimulators (i.e.TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF or IFC(Interferential current),or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use.

Source page: https://510kreport.com/device/K222453
Methodology: https://510kreport.com/methodology