# K111270: Reusable Stimulating Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Bio Protech, Inc.
- Decided: Sep 13, 2011 after 133 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K161282: FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W (2016), 0 descendants of its own

## Indications for use
Blo Protech Reusable Stimulating electrodes are intended to be used to apply electrical stimulation current to the patient's skin or to record physiological signals. Electrical stimulation current applications of these electrodes are: a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief. b) Electrical muscle stimulation (EMS) c) Functional electrical stimulation (FES) d) Microcurrent electrical nerve stimulation (MENS) e) Interferential stimulation (IF) f) Neuromuscular electrical stimulation (NMES)

Source page: https://510kreport.com/device/K111270
Methodology: https://510kreport.com/methodology