# K161282: FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W

- Pathway: 510(k) (Traditional)
- Applicant: Medico Electrodes International, Ltd.
- Decided: Oct 30, 2016 after 177 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: 1 generation back to K111270 (2011). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142099: Cutaneous Electrodes, Bio Protech, Inc. (2014) Summary page 4.
- K111270: Reusable Stimulating Electrodes, Bio Protech, Inc. (2011) Summary page 4.

## Indications for use
Reusable, self-adhering neurostimulation electrodes are indicated for use with transcutaneous electrical stimulation devices. Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices. Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.

Source page: https://510kreport.com/device/K161282
Methodology: https://510kreport.com/methodology