# K132998: Wandy Self-Adhesive Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Wandy Rubber Industrial Co., Ltd.
- Decided: Dec 20, 2013 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: 5 generations back to K903402 (1990). 10 ancestors in all.
16 later devices descend from it; 4 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)
- K002219: Wandy Self-Adhesive Neurostimulation Electrode, Wandy Rubber Industrial Co., Ltd. (2001) Summary page 3.
- K002227: Wandy Silicone Conductive Rubber Pad, Wandy Rubber Industrial Co., Ltd. (2001) Summary page 3.
- K090198: Jiajian Self-Adhesive Electrode, Wuxi Jiajian Medical Instrument Co., Ltd. (2009) Summary page 1.

## Most influential descendants
- K160138: Adhesive Electrodes (2016), 15 descendants of its own
- K180865: ZMI Self-Adhesive Electrodes (2018), 9 descendants of its own
- 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

## Indications for use
Wendy Self-adhesive Electrode is intended to transmit electrical current to patient skin, for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation) applications, for OTC (Over-The -Counter) or Prescription use. The Electrode are used for adults only.

Source page: https://510kreport.com/device/K132998
Methodology: https://510kreport.com/methodology