# K223775: EZ-STIK Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: South Dakota Partners
- Decided: Jan 3, 2023 after 18 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 K903402 (1990). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050469: EZ-Stik Electrodes, Naimco, Inc. (2005) Summary page 4.
- K160138: Adhesive Electrodes, Gmdasz Manufacturing Co., Ltd. (2016) Summary page 4.

## Indications for use
The EZ-STIK Electrodes are intended for use as a disposable, reusable, conductive adhesive interface between the patient's skin and the electrical stimulator. The EZ-STIK Electrodes are designed and intended to be used with marketed electrical stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscle Stimulation), IF (Inferential), or PGF (Pulsed Galvanic Stimulation). The electrode is for OTC (Over-the-Counter) or Prescription Use.

Source page: https://510kreport.com/device/K223775
Methodology: https://510kreport.com/methodology