Intco Tab Electrode
by Shanghai Intco Electrode Manufacturing Co., Ltd.
510(k) K093327
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK093327 | Date10 May 2010 | 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- Withdrawn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, 19 Sep 2026
The Intco Tab Electrode is a disposable adhesive electrode designed for use in electrocardiography (ECG) and related cardiac monitoring applications. It facilitates the attachment of monitoring leads to the patient’s skin, enabling accurate detection and recording of electrical activity from the heart.
These electrodes are supplied sterile and intended for single-use only, adhering to standard ECG lead configurations. They are classified under product code DRX and comply with FDA 510(k) clearance (K093327) as substantially equivalent to predicate devices. Storage requires protection from moisture and extreme temperatures, and they are regulated under the Cardiovascular advisory committee classification.
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Questions
AI-generated answers, 19 Sep 2026
What types of procedures or applications is the Intco Tab Electrode specifically designed for?
The Intco Tab Electrode is designed exclusively for electrocardiography (ECG) and related cardiac monitoring applications. It is used to attach monitoring leads to a patient’s skin, ensuring accurate detection and recording of the heart’s electrical activity. This makes it suitable for clinical settings where continuous or periodic ECG monitoring is required, such as in hospitals, emergency rooms, or outpatient cardiac evaluations.
Are these electrodes reusable, or are they intended for single-use only?
The Intco Tab Electrode is explicitly intended for single-use only. This design choice ensures patient safety, hygiene, and reliability, as reuse could compromise sterility and performance. The manufacturer emphasizes this in their specifications to align with best practices in medical device usage.
How should I store these electrodes to maintain their integrity and sterility?
Storage requires protection from moisture and extreme temperatures. The electrodes should be kept in their original packaging until use, ensuring they remain dry and within recommended environmental conditions. Proper storage prevents degradation of adhesive properties and maintains sterility, which is critical for single-use medical devices.
What regulatory pathway does the Intco Tab Electrode follow, and which committee oversees its classification?
The Intco Tab Electrode follows the FDA 510(k) clearance pathway, classified under product code DRX and regulated by the Cardiovascular (CV) Advisory Committee. It was determined to be substantially equivalent to predicate devices, with clearance granted on May 10, 2010 (K093327). This classification reflects its use in cardiac monitoring applications.