Disposable and Reusable Concentric Needle Electrodes, Disposable and Reusable Subdermal Needle Electrodes
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K130136 FDA 510(k)
- FDA Product Code
- GXZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1350 FDA 510(k)
- Regulation Number
- 882.1350 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
These devices are concentric and subdermal needle electrodes designed for electromyography (EMG) and neurological assessments. Concentric needle electrodes combine a stimulating and recording electrode within a single needle, enabling precise muscle and nerve signal acquisition, while subdermal needle electrodes facilitate deep tissue signal detection for diagnostic purposes.
The electrodes are available in both disposable and reusable forms, with the disposable variants pre-sterilized for single-use applications. They are classified as Class II medical devices under FDA regulations and comply with the Medical Device Directive (MDD). Supplied in various sizes and configurations, these electrodes are intended for use in clinical settings such as neurology departments, with no MRI safety restrictions specified. Authorisations include FDA 510(k) clearance and MDD compliance.
Frequently asked questions
Are these needle electrodes suitable for repeated use in clinical settings, or are they strictly single-use only?
These electrodes come in both disposable and reusable forms. The disposable variants are pre-sterilized for single-use applications, while the reusable models are designed for multiple uses with appropriate cleaning and sterilization procedures between patients. This dual offering allows clinicians to choose based on their workflow and infection control protocols.
What types of procedures or assessments are these electrodes primarily intended for?
These concentric and subdermal needle electrodes are specifically designed for electromyography (EMG) and neurological assessments. The concentric electrodes combine a stimulating and recording electrode within a single needle, ideal for precise muscle and nerve signal acquisition, while the subdermal electrodes facilitate deep tissue signal detection for diagnostic purposes in neurology departments.
How many different sizes or configurations are available for these electrodes, and how do I determine which one to use?
The electrodes are supplied in various sizes and configurations, as indicated by the multiple registration numbers and product codes listed. While the exact specifications for each size aren’t detailed here, the variety ensures compatibility with different patient anatomies and clinical needs. Clinicians should refer to the manufacturer’s documentation or consult with Technomed Europe to select the appropriate size based on the specific procedure or patient requirements.
Do these electrodes have any restrictions regarding use in environments with magnetic resonance imaging (MRI) equipment?
The device data does not specify any MRI safety restrictions for these electrodes. However, it’s always critical to verify compatibility with MRI equipment and protocols before use in an MRI environment, as even non-ferromagnetic materials may pose risks depending on the specific MRI system and settings.
What regulatory pathways have these electrodes undergone, and how does that impact their use in clinical settings?
These electrodes have undergone FDA 510(k) clearance and comply with the Medical Device Directive (MDD), confirming they meet regulatory standards for safety and effectiveness. The FDA classification is Class II, indicating they are subject to special controls to ensure their performance and safety. Clinicians can rely on these regulatory pathways as evidence of the electrodes’ suitability for use in clinical neurology assessments.
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: Technomed Disposable Concentric Needle Electrodes, PDF PRODUCT CATALOGUE - technomedmedical.com, TECA® Elite Disposable Concentric EMG Needle Electrodes, Concentric EMG Needle Electrodes - neurosupply.com, Rhythmlink Disposable Concentric Needle Electrodes | INM ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K130136 | Class II | Active |
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Manufacturer
- Manufacturer
- Technomed Europe
Sources (2)
- FDA 510(k) K130136 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026