# K253237: Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)

- Pathway: 510(k) (Traditional)
- Applicant: Elde Medikal Sanayi ve Ticaret Anonim Sirketi
- Decided: May 8, 2026 after 221 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: 10 generations back to K945676 (1995). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241512: Electrode Pad, Shenzhen Deliduo Medical Technology Co.,Ltd (2025) Summary page 5.

## Indications for use
The Elde Medical electrode is intended to transmit electrical current to the patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limited to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-the-Counter) or Prescription use.

Source page: https://510kreport.com/device/K253237
Methodology: https://510kreport.com/methodology