# K250841: Electrotherapy Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Baisheng Medical Co., Ltd.
- Decided: Aug 13, 2025 after 146 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 K903402 (1990). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180865: ZMI Self-Adhesive Electrodes, Zmi Electronics, Ltd. (2018) Summary page 6.

## Indications for use
Electrotherapy Electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Electrotherapy Electrodes are intended to be used with marketed Electrical Stimulators, (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation)) for transmitting electrical current. The electrodes are for OTC (Over-The-Counter) or Prescription use.

Source page: https://510kreport.com/device/K250841
Methodology: https://510kreport.com/methodology