# K202636: Metallic Fabric Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Xinbo Electronic Co., Ltd.
- Decided: Aug 16, 2021 after 339 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
Metallic Fabric Electrodes are cutaneous electrodes to be used with legally marketed TENS or NMES devices. The Metallic Fabric Electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include wrist, elbow or arm, knee or leg and back band.

Source page: https://510kreport.com/device/K202636
Methodology: https://510kreport.com/methodology