# K180865: ZMI Self-Adhesive Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Zmi Electronics, Ltd.
- Decided: Jun 28, 2018 after 87 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: 7 generations back to K903402 (1990). 17 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132998: Wandy Self-Adhesive Electrodes, Wandy Rubber Industrial Co., Ltd. (2013) Summary page 4.
- K160138: Adhesive Electrodes, Gmdasz Manufacturing Co., Ltd. (2016) Summary page 4.

## Most influential descendants
- K222252: Self-adhesive Electrode (2023), 6 descendants of its own
- 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

## Indications for use
ZMI Self-adhesive electrodes are 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 (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrodes are for OTC (Over-The-Counter) or Prescription use.

Source page: https://510kreport.com/device/K180865
Methodology: https://510kreport.com/methodology