Self-Adhesive Electrode
by Bozhou Rongjian Medical Appliance Co., Ltd.
510(k) K213879
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK213879 | Date5 Jan 2022 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- GXY
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1320
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Self-Adhesive Electrode is a Cutaneous Electrode (per 21 CFR 882.1320), designed for non-invasive attachment to the skin to facilitate electrical signal transmission in neurological applications. These electrodes provide a reliable interface for monitoring or stimulating nerve activity, commonly used in electrodiagnostic procedures and neuromuscular assessments.
Supplied as a single-use or reusable device (as specified by the manufacturer), the Self-Adhesive Electrode is intended for clinical settings where sterile or non-sterile use may be required. It adheres directly to the skin without the need for additional preparation agents, ensuring ease of application and removal. Regulated under FDA 510(k) clearance (K213879) and MDR, compliance with 21 CFR 882.1320 ensures adherence to safety and performance standards for Class II medical devices.
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Questions
AI-generated answers, 18 Sep 2026
What types of clinical procedures is this self-adhesive electrode primarily used for?
This self-adhesive electrode is designed for non-invasive electrical signal transmission in neurological applications, making it suitable for electrodiagnostic procedures and neuromuscular assessments. Its primary use is facilitating reliable monitoring or stimulation of nerve activity during these evaluations.
Can this electrode be reused, or is it intended for single-use only?
The electrode can be supplied as either single-use or reusable, depending on the specific model or configuration chosen by the manufacturer. This flexibility allows clinical settings to select the appropriate option based on their sterile or non-sterile requirements and infection control protocols.
How does the electrode adhere to the skin, and does it require any additional preparation?
The electrode is designed for direct, self-adhesive application to the skin without needing additional preparation agents like gels or pastes. This ensures ease of use, quick application, and minimal discomfort for the patient during procedures.
What regulatory pathways does this device follow, and what does that mean for compliance?
This self-adhesive electrode is regulated under both FDA 510(k) clearance (K213879) and the EU’s Medical Device Regulation (MDR). The FDA clearance indicates it meets Class II standards under 21 CFR 882.1320, while MDR compliance ensures it adheres to EU safety and performance requirements for medical devices.
Are there different sizes or models available for this electrode, and how might that affect selection?
While the provided data does not specify exact sizes or models, the electrode is categorized under product code GXY and is designed for general cutaneous use in neurological applications. Clinicians should refer to the manufacturer’s documentation for available variations, as these may influence compatibility with specific monitoring or stimulation devices and patient anatomy.