# K050469: EZ-Stik Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Naimco, Inc.
- Decided: May 13, 2005 after 79 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945676 (1995). 3 ancestors in all.
40 later devices descend from it; 3 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945676: Guardian Disposable Tens and Tens/Nmes Electrodes, Selectivemed Components, Inc. (1995) Summary page 1.
- K970426: Valuetrode, Axelgaard Mfg. Co., Ltd. (1997) Summary page 1.
- K012463: Lifecare 5*5 CM Square, Lifecare 4*4 CM Square, Lifecare 5 CM Round, Lifecare 7.5 CM Round, Lifecare 4*6 CM Oval, Everyway Medical Instruments Co.,Ltd (2002) Summary page 1.

## Most influential descendants
- K052875: Prostim Reusable Neurostimulation Electrodes (2005), 22 descendants of its own
- K062675: Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and Double Side Series (2007), 21 descendants of its own
- K092546: Gmdasz Tens Electrodes, Models CWN1005, Dia. 5CM, DWN2505, 5CMX5CM, CWN1007.Dia. 7CM, CWN2509,5CMX9CM (2009), 16 descendants of its own
- K160138: Adhesive Electrodes (2016), 15 descendants of its own
- K083302: Lifecare Electrodes (2009), 14 descendants of its own

## Recalls of this device
- Nov 30, 2009 · Class II · Z-0815-2013: Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
- Nov 30, 2009 · Class II · Z-0816-2013: Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
- Nov 30, 2009 · Class II · Z-0817-2013: Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
- Nov 30, 2009 · Class II · Z-0818-2013: Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.

## Indications for use
The NAlmco, Inc. EZ-stik electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. NAImco's reusable electrodes are designed and 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).

Source page: https://510kreport.com/device/K050469
Methodology: https://510kreport.com/methodology