Identifiers
- 510(k) Number
- K223775 FDA 510(k)
- FDA Product Code
- GXY 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 Ez-Stik Electrodes are cutaneous electrodes, classified as a Class II device under the regulation number 21 CFR 882.1320. They have a 3-layer construction of non-woven polyester material or soft PVC foam, carbon film coated with silver and conductive hydrogel.
The Ez-Stik Electrodes are reusable, flexible structures composed of laminated materials. They are supplied with a product code of GXY and have been cleared under FDA 510(k) with the k number K223775. The device is intended for use as a cutaneous electrode.
Frequently asked questions
What are EZ-STIK Electrodes used for?
The EZ-STIK Electrodes are intended for use as cutaneous electrodes, providing a flexible and reusable structure for medical applications.
How are EZ-STIK Electrodes supplied?
The EZ-STIK Electrodes are supplied with a product code of GXY, indicating their classification and regulatory clearance.
Are EZ-STIK Electrodes reusable?
Yes, the EZ-STIK Electrodes are reusable, composed of laminated materials that allow for repeated use.
What is the regulatory status of EZ-STIK Electrodes?
The EZ-STIK Electrodes have been cleared under FDA 510(k) with the k number K223775, indicating substantial equivalence to existing devices.
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: K223775 FDA 510(k) - EZ-STIK Electrodes | South Dakota Partners, EZ-STIK Electrodes (K223775) — FDA 510 (k) | Innolitics, PDF South Dakota Partners ℅ Dave Yungvirt Official Correspondent Third ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223775 | Class II | Active |
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Manufacturer
- Manufacturer
- South Dakota Partners
Sources (1)
- FDA 510(k) K223775 24 fields · synced Sep 27, 2026