Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K152984 FDA 510(k)
- FDA Product Code
- IKT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.1385 FDA 510(k)
- Regulation Number
- 890.1385 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
These devices are disposable needle electrodes designed for electromyographic (EMG) and electrophysiological (EP) assessments. They function as passive sensors to capture biopotential signals from muscle or nerve tissue, transmitting data via lead wires to external EMG or EEG recording equipment. The hypodermic variant includes a lumen for Botulinum Toxin injection, enabling dual functionality in clinical diagnostics and therapeutic procedures.
Intended for single-use in clinical settings, these electrodes are manufactured with silver electrode core wire to enhance signal quality and reduce noise. They are supplied sterile and require no reprocessing. The devices comply with FDA 510(k) clearance, MDD, and MDR regulations, classified under Device Class II for diagnostic electromyography. Storage instructions and MRI safety are not specified in the provided data.
Frequently asked questions
Are these needle electrodes reusable or designed for single-use, and why does that matter for clinical workflows?
These electrodes are explicitly designed for single-use only, as stated in the description. This eliminates the need for reprocessing, reducing the risk of contamination and ensuring consistent performance for each patient. Single-use also simplifies inventory management and compliance with infection control protocols, making them ideal for clinical workflows where sterility and patient safety are critical.
What types of clinical procedures or assessments are these electrodes primarily used for, and how do they differ from standard surface electrodes?
These disposable needle electrodes are specifically designed for electromyographic (EMG) and electrophysiological (EP) assessments, allowing precise signal capture from muscle or nerve tissue—unlike surface electrodes, which only measure superficial signals. The hypodermic variant also includes a lumen for Botulinum Toxin injection, enabling dual use in both diagnostic testing and therapeutic procedures. Their needle design ensures deeper tissue penetration for accurate readings.
How are these electrodes supplied, and what should clinicians check before use to ensure proper functionality?
The electrodes are supplied sterile and packaged for single-use, as noted in the description. Clinicians should verify the sterility seal and expiration date before use. Since they are passive sensors connected via lead wires to external EMG/EEG equipment, they require proper connection to compatible recording devices for accurate signal transmission. No reprocessing is needed, but damaged or compromised packaging should be discarded.
What regulatory pathways have these devices undergone, and how does that affect their use in clinical settings?
These electrodes are FDA 510(k) cleared, compliant with the Medical Device Directive (MDD) and Medical Device Regulation (MDR), and classified as Class II diagnostic devices under FDA regulations. This means they meet stringent safety and performance standards for electromyography, ensuring reliability for clinical use. The regulatory route confirms their suitability for electrophysiological assessments in physical medicine settings, as referenced in the advisory committee and product codes.
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 Concentric Needle electrodes, Disposable Monopolar Needle ..., Neurology - Bio-Protech, Disposable Concentric Needle Electrodes, Disposable Monopolar Needle ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K152984 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio Protech Inc.
- FDA Applicant
- Bio Protech, Inc.
Sources (2)
- FDA 510(k) K152984 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026