# K182111: DL Self-adhesive Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Shaoxing DL Healthcare Co., Ltd.
- Decided: Jan 17, 2019 after 164 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: 8 generations back to K945676 (1995). 24 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152648: Ennova Self-adhesive Electrode, Suzhou Ennova Electronics Technology Co.,Ltd (2016) Summary page 5.
- K100418: Superior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating Electrode, Covidien (2010) Summary page 5.

## Most influential descendants
- K241512: Electrode Pad (2025), 1 descendant of its own
- K253237: Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) (2026), 0 descendants of its own
- K183154: SM Electrodes (2019), 0 descendants of its own

## Indications for use
DL Adhesive Electrode is intended to transmit electrical current to 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/K182111
Methodology: https://510kreport.com/methodology