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Disposable EEG Electrodes (MODEL: DL +2 more)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K200162

by Wuhan Greentek Pty Ltd.

Identifiers

510(k) Number
K200162 FDA 510(k)
FDA Product Code
GXY FDA 510(k)
Models / Variants
MODEL: DL FDA 510(k)EUDAMED
E-CAP FDA 510(k)EUDAMED
FLEX-CAP FDA 510(k)EUDAMED

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 Disposable EEG Electrodes (Models DL, E-CAP, FLEX-CAP) are single-use, cutaneous electrodes designed for electroencephalography (EEG) recording. They facilitate precise and uniform placement of 2 to 128 electrodes on the patient’s scalp, enabling accurate monitoring of brain electrical activity in clinical settings.

These electrodes are supplied sterile and intended for single-use only, adhering to FDA 510(k) clearance (K200162) and MDR compliance. They are classified under product code GXY as Class II devices under special controls for neurology applications, with models available in varying configurations to accommodate different EEG electrode counts. Storage and handling must comply with manufacturer guidelines to maintain sterility and performance.

Frequently asked questions

Are these EEG electrodes reusable, or are they meant for single-use only?

These electrodes are explicitly designed for single-use only, as stated in the manufacturer’s instructions. They are supplied sterile and intended to be discarded after one use to ensure patient safety and maintain accuracy in EEG recordings.

What range of electrode counts are available for these disposable EEG electrodes?

The product line includes configurations supporting 2 to 128 electrodes, allowing flexibility for different clinical EEG monitoring needs, from basic setups to high-density scalp recordings.

How should I store these electrodes to keep them sterile and functional?

Storage and handling must follow the manufacturer’s guidelines to preserve sterility and performance. Since they are sterile upon supply, they should remain in their original packaging until use and be protected from contamination or environmental damage.

What regulatory pathways have these electrodes followed for approval?

These electrodes are cleared under FDA 510(k) (K200162) and comply with MDR (Medical Device Regulation) standards. They fall under product code GXY, classified as Class II devices under special controls for neurology applications.

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: Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) (K200162) — FDA ..., Disposable EEG Electrodes (MODEL: DL, E... (K200162) - FDA 510(k), Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP), Disposable EEG Electrodes (MODEL: DL, E... (K200162) - FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Wuhan Greentek Pty Ltd.
FDA Applicant
Wuhan Greentek Pty , Ltd.

Sources (2)

  • FDA 510(k) K200162 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026