# K252439: Tutamen Self Adhesive Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Tutamen Metalwork Co., Ltd.
- Decided: May 1, 2026 after 270 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: 6 generations back to K903402 (1990). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213879: Self-adhesive Electrode, Bozhou Rongjian Medical Appliance Co., Ltd. (2022) Summary page 5.

## Indications for use
The Self-Adhesive Electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS

Source page: https://510kreport.com/device/K252439
Methodology: https://510kreport.com/methodology