Pregelled Dispos. Elect., Silver-Silver Chloride
510(k) K863366
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK863366 | Date21 Nov 1986 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DRX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2360
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a disposable pre-gelled electrode classified under FDA product code DRX (Disposable Electrodes). It features silver-silver chloride conductive material, designed for temporary attachment to the skin to facilitate electrical conduction in cardiovascular monitoring and diagnostic procedures. The electrode is intended for single-use applications, ensuring sterile and reliable performance in electrophysiological assessments.
The electrodes are supplied in a sterile, single-use configuration, packaged in quantities of 100 per box. They require reusable alligator clip lead wires for connection and are intended for use in neuromuscular and somatosensory evoked potential (NCS/SEP) testing. Compliance with FDA 510(k) clearance (K863366) ensures adherence to regulatory standards for disposable electrodes (870.2360). Storage should follow manufacturer guidelines to maintain sterility and functionality.
Other devices from Labeltape Meditect, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the PREGELLED DISPOS. ELECTRODE, Silver-Silver Chloride used for?
This electrode is designed for temporary skin attachment to facilitate electrical conduction during cardiovascular monitoring and diagnostic procedures. Its primary use is in neuromuscular and somatosensory evoked potential (NCS/SEP) testing, where stable and accurate signal transmission is critical for assessing nerve and muscle function.
How is the electrode supplied, and what packaging ensures its sterility?
The electrodes are supplied in sterile, single-use packaging, with each box containing 100 pre-gelled electrodes. The pre-gelled design and sterile packaging ensure reliable performance and reduce the risk of contamination, making them ideal for clinical use without additional preparation.
Are these electrodes reusable, or are they intended for single-use?
These electrodes are explicitly designed for single-use applications. The sterile packaging and pre-gelled material are optimized for one-time clinical use, ensuring consistent performance and minimizing cross-contamination risks in healthcare settings.
What type of lead wires are required for use with these electrodes?
The electrodes require reusable alligator clip lead wires for connection. These lead wires are designed to securely attach to the electrodes, enabling reliable electrical conduction during monitoring or diagnostic procedures.
How should these electrodes be stored to maintain their sterility and functionality?
Storage should follow the manufacturer’s guidelines to preserve sterility and functionality. This typically involves keeping the electrodes in their original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures until use.