# K092546: Gmdasz Tens Electrodes, Models CWN1005, Dia. 5CM, DWN2505, 5CMX5CM, CWN1007.Dia. 7CM, CWN2509,5CMX9CM

- Pathway: 510(k) (Traditional)
- Applicant: Gmdasz Manufacturing Co., Ltd.
- Decided: Dec 18, 2009 after 121 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: 2 generations back to K945676 (1995). 4 ancestors in all.
16 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970426: Valuetrode, Axelgaard Mfg. Co., Ltd. (1997) Summary page 1.
- K050469: EZ-Stik Electrodes, Naimco, Inc. (2005) Summary page 1.

## Most influential descendants
- K160138: Adhesive Electrodes (2016), 15 descendants of its own
- K180865: ZMI Self-Adhesive Electrodes (2018), 9 descendants of its own
- K222252: Self-adhesive Electrode (2023), 6 descendants of its own
- K223802: accufit (2023), 5 descendants of its own
- K233926: accufit (2024), 4 descendants of its own

## Indications for use
The GMDASZ TENS Electrodes are intended for use as a reusable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. GMDASZ'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). The electrotherapy electrodes are intended to be used to apply electrical stimulation current to the patient's skin.

Source page: https://510kreport.com/device/K092546
Methodology: https://510kreport.com/methodology