# K121816: Sensus Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Neurometrix, Inc.
- Decided: Nov 26, 2012 after 159 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 K010431 (2001). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010431: Lead-Lok Reusable Tens/ Nmes Electrodes, Lead-Lok, Inc. (2001) Summary page 2.

## Most influential descendants
- K140586: Ascend Electrode (2014), 1 descendant of its own
- K230533: Motive™ Electrode (2023), 0 descendants of its own

## Indications for use
The Neuro~etrix SENSUS Electrode is intended for use as disposable, conductive, adhesive interface between the patient's skin and a transcutaneous, electrical nerve stimulator.

Source page: https://510kreport.com/device/K121816
Methodology: https://510kreport.com/methodology