Biotac Eco Electrode
510(k) K950488
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK950488 | Date3 Jul 1995 | 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- Withdrawn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
- Full name
- Graphic Controls Biotac Eco Electrode
- 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
The Biotac Eco Electrode is a disposable adhesive electrode designed for use in electrocardiogram (ECG) monitoring and related cardiovascular diagnostic procedures. It facilitates the attachment of monitoring leads to the patient’s skin, enabling accurate detection and transmission of electrical signals from the heart. As a component of ECG systems, it plays a critical role in assessing cardiac function and rhythm. Its classification aligns with electrocardiographic electrodes intended for temporary diagnostic use.
Supplied as a single-use, sterile device, the Biotac Eco Electrode is intended for clinical settings where ECG monitoring is performed. It adheres to standard sterility and single-patient-use protocols to ensure patient safety and prevent cross-contamination. The device is regulated under FDA 510(k) clearance (K950488) and falls under the Product Code DRX, reflecting its classification as a diagnostic electrode. Storage and handling follow standard medical device protocols for adhesive electrodes, with no specific MRI safety considerations noted.
Other devices from Graphic Controls Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Biotac Eco Electrode used for?
The Biotac Eco Electrode is designed specifically for electrocardiogram (ECG) monitoring and related cardiovascular diagnostic procedures. It facilitates the attachment of monitoring leads to the patient’s skin, enabling precise detection and transmission of the heart’s electrical signals. This allows clinicians to assess cardiac function and rhythm accurately, supporting diagnostic evaluations in clinical settings.
Is the Biotac Eco Electrode single-use or reusable?
The Biotac Eco Electrode is intended for single-use only. This design ensures patient safety by preventing cross-contamination between patients and adheres to standard sterility protocols for medical devices. After use, the electrode should be discarded to maintain hygiene and compliance with clinical guidelines.
How should the Biotac Eco Electrode be stored?
Storage follows standard medical device protocols for adhesive electrodes. The device should be kept in a clean, dry environment, protected from extreme temperatures and direct sunlight. Ensure the packaging remains intact until immediate use to preserve sterility. Avoid storing near sources of contamination or moisture, as this could compromise the electrode’s integrity.
What regulatory clearance does the Biotac Eco Electrode hold?
The Biotac Eco Electrode holds FDA 510(k) clearance under the reference number K950488. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and meets regulatory requirements for diagnostic electrocardiographic electrodes intended for temporary use. The classification aligns with Product Code DRX.
Are there any special considerations for handling or use with MRI?
No specific MRI safety considerations are noted for the Biotac Eco Electrode. However, as with all medical devices, it should not be used in MRI environments unless explicitly approved for such use by the manufacturer. Always verify compatibility with the MRI system and follow facility protocols to ensure patient and staff safety.