# K183154: SM Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Hong Qiangxing (Shenzhen) Electronics Limited
- Decided: Mar 26, 2019 after 132 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: 9 generations back to K945676 (1995). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 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.
- K182111: DL Self-adhesive Electrode, Shaoxing DL Healthcare Co., Ltd. (2019). Cleared while this submission was under review Summary page 5.

## Indications for use
SM Electrodes are 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/K183154
Methodology: https://510kreport.com/methodology