# K212191: Adhesive Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Voncare Medical Device Co., Ltd.
- Decided: Oct 6, 2021 after 86 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.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

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

## Indications for use
The 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 electrode is for OTC (Over-The-Counter) or Prescription use.

Source page: https://510kreport.com/device/K212191
Methodology: https://510kreport.com/methodology