← Back to catalogue

Gmdasz Tens Electrodes (Cwn1005 +6 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K092546

by Gmdasz Manufacturing Co., Ltd.

Identifiers

510(k) Number
K092546 FDA 510(k)
FDA Product Code
GXY FDA 510(k)
Models / Variants
Cwn1005 FDA 510(k)
Dia. 5cm FDA 510(k)
Dwn2505 FDA 510(k)
5cmx5cm FDA 510(k)
Cwn1007.dia. 7cm FDA 510(k)
Cwn2509 FDA 510(k)
5cmx9cm FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1320 FDA 510(k)
Regulation Number
882.1320 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The GMDASZ TENS Electrodes are reusable adhesive electrodes designed for transcutaneous electrical nerve stimulation (TENS). These electrodes deliver low-voltage electrical currents to the skin for pain management, typically used in neurology for chronic pain relief or muscle stimulation therapies.

These electrodes are supplied sterile and intended for single-use applications, adhering to FDA Class II standards under 21 CFR 882.1320. Available in four distinct sizes—CWN1005 (5 cm diameter), DWN2505 (5 cm x 5 cm), CWN1007 (7 cm diameter), and CWN2509 (5 cm x 9 cm)—they are regulated under a 510(k) clearance (K092546) and classified as substantially equivalent to predicate devices. Storage and handling follow standard medical device protocols to maintain sterility and functionality.

Frequently asked questions

Are these TENS electrodes meant for repeated use or single-use, and how should they be stored to maintain their condition?

These GMDASZ TENS electrodes are labeled for single-use applications despite being reusable adhesive electrodes. They are supplied sterile, so storage must follow standard medical device protocols to preserve sterility and functionality. Keep them in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensure the packaging remains intact until use.

What sizes are available for the GMDASZ TENS electrodes, and how might I choose the right one for a patient?

The GMDASZ TENS electrodes come in four sizes: 5 cm diameter (CWN1005), 5 cm x 5 cm (DWN2505), 7 cm diameter (CWN1007), and 5 cm x 9 cm (CWN2509). Selection depends on the treatment area—smaller electrodes (like CWN1005) are ideal for precise targeting, while larger ones (like CWN2509) provide broader coverage for muscle stimulation or larger pain zones.

How were these electrodes reviewed by the FDA, and what does their classification mean for clinical use?

The GMDASZ TENS electrodes were reviewed by the Neurology (NE) Advisory Committee under a traditional 510(k) pathway and classified as substantially equivalent (SESE) to predicate devices. This means they meet FDA standards for transcutaneous electrical nerve stimulation (TENS) applications in pain management, particularly for chronic pain relief or muscle stimulation, and are regulated under 21 CFR 882.1320 as Class II devices.

Can these electrodes be used for both pain relief and muscle stimulation, and what makes them suitable for these purposes?

Yes, these electrodes are designed for transcutaneous electrical nerve stimulation (TENS), which can be used for both pain management and muscle stimulation. Their adhesive, reusable (though sterile for single-use) design ensures secure placement on the skin, while their low-voltage electrical delivery targets nerve pathways to relieve chronic pain or stimulate muscle activity, making them versatile for neurology-related therapies.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Gmdasz Tens Electrodes, Models Cwn1005, Dia. 5cm, Dwn2505, 5cmx5cm ..., Gmdasz Tens Electrodes, Models Cwn1005, Dia. 5cm, Dwn2505, 5cmx5cm ..., Gmdasz Tens Electrodes, Models Cwn1005, Dia. 5cm, Dwn2505, 5cmx5cm ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Gmdasz Manufacturing Co., Ltd.

Sources (1)

  • FDA 510(k) K092546 24 fields · synced Sep 19, 2026