Skintact Ag Electrodes
510(k) K862618
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK862618 | Date15 Sep 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- Withdrawn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, 19 Sep 2026
The Skintact Ag Electrodes are adhesive, disposable electrodes designed for electrocardiographic (ECG) monitoring, defibrillation, electrosurgery, and neuromuscular stimulation. These electrodes facilitate the transmission of electrical signals between medical devices and the patient’s skin, ensuring accurate and reliable diagnostic or therapeutic applications.
These electrodes are supplied as single-use, sterile devices and are intended for use in clinical settings such as hospitals, emergency rooms, and outpatient care. They are classified under product code DRX and were granted FDA 510(k) clearance (K862618) as substantially equivalent to a predicate device in 1986. Storage and handling should comply with standard medical device protocols to maintain sterility and performance.
Questions
AI-generated answers, 19 Sep 2026
What clinical applications are these electrodes primarily designed for, and how do they function in those settings?
The Skintact Ag Electrodes are designed for electrocardiographic (ECG) monitoring, defibrillation, electrosurgery, and neuromuscular stimulation. They transmit electrical signals between medical devices and a patient’s skin, ensuring accurate diagnostic readings (like ECG) or effective therapeutic interventions (such as defibrillation). Their adhesive, disposable nature makes them ideal for clinical settings like hospitals, emergency rooms, and outpatient care, where reliable signal transmission is critical.
Are these electrodes reusable, and if not, what precautions should be taken during storage to maintain their integrity?
No, the Skintact Ag Electrodes are single-use, sterile devices, so they cannot be reused. To preserve sterility and performance, storage must follow standard medical device protocols—typically in a clean, dry environment away from direct sunlight or extreme temperatures. The manufacturer’s packaging should remain intact until use.
What regulatory pathway was followed for FDA clearance, and how does that affect their use in the U.S.?
These electrodes received FDA 510(k) clearance (K862618) in 1986 under the Traditional Review pathway, determined to be *substantially equivalent* to a predicate device. This means they meet U.S. safety and performance standards for their intended uses (ECG monitoring, defibrillation, etc.) and can legally be marketed in the U.S. without additional approvals for those applications.
How do I know which size or model of Skintact Ag Electrodes to select for a patient?
The provided specifications do not list explicit size or model variations, but Skintact Ag Electrodes are designed as adhesive, disposable electrodes for general clinical use. Selection typically depends on patient anatomy (e.g., chest size for ECG leads) and the specific medical device being used. Always refer to the manufacturer’s instructions or the device’s user manual for compatibility guidance.