# K112312: Theratrode

- Pathway: 510(k) (Traditional)
- Applicant: Phoenix Medical Devices, Llp
- Decided: Jan 25, 2012 after 167 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: 5 generations back to K945676 (1995). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083302: Lifecare Electrodes, Everyway Medical Instruments Co.,Ltd (2009) Summary page 2.

## Most influential descendants
- K152815: Mailuokang Self-adhesive Electrode (2016), 1 descendant of its own
- K181234: Self-adhesive Electrode (2018), 0 descendants of its own

## Indications for use
To conduct electrical stimulation from common varieties of electrical stimulators to the patients skin. Single patient use - re-usable. Self adhering and re-positionable. Over the counter use.

Source page: https://510kreport.com/device/K112312
Methodology: https://510kreport.com/methodology