# K222252: Self-adhesive Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Roundwhale Technology Co., Ltd.
- Decided: Jan 19, 2023 after 176 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.
6 later devices descend from it; 1 cites it directly.
0 of 25 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.
- K160138: Adhesive Electrodes, Gmdasz Manufacturing Co., Ltd. (2016) Summary page 5.

## Most influential descendants
- K223802: accufit (2023), 5 descendants of its own
- K233926: accufit (2024), 4 descendants of its own
- K241685: SofWave System (2024), 2 descendants of its own
- K250146: SofWave System (2025), 1 descendant of its own
- K251594: truFlex (2025), 0 descendants of its own

## Indications for use
Self-Adhesive Electrode is intended for use 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/K222252
Methodology: https://510kreport.com/methodology