# K221199: Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)

- Pathway: 510(k) (Traditional)
- Applicant: Green Island International Tcm Group Limited
- Decided: Dec 19, 2023 after 602 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Conductive Silicone Electrode is intended to be used with legally marketed electrical stimulation devices such as transcutaneous electrical nerve stimulators. Conductive Silicone Electrode will deliver the stimulation signals generated by the stimulator to the surface where it is in contact with.

Source page: https://510kreport.com/device/K221199
Methodology: https://510kreport.com/methodology