# K152648: Ennova Self-adhesive Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Ennova Electronics Technology Co.,Ltd
- Decided: Feb 18, 2016 after 155 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: 7 generations back to K945676 (1995). 20 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150971: Zekang Self-adhesive Electrode, Jiangsu Zekang Medical Technology Co., Ltd. (2015) Summary page 5.
- K090198: Jiajian Self-Adhesive Electrode, Wuxi Jiajian Medical Instrument Co., Ltd. (2009) Summary page 5.

## Most influential descendants
- K182111: DL Self-adhesive Electrode (2019), 3 descendants of its own
- 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
Ennova Self-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 limit 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/K152648
Methodology: https://510kreport.com/methodology