Skintact Radiotransparent Multifunction Electrodes

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K103186 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Skintact

  Class I

  CE/MDR

• megro

  Class I

  CE/MDR

• Skintact and Various Other Tradenames

  Class II

  FDA 510(k) K073104 Active Cleared 16 Nov 2007

• Skintact Multifunction Electrodes, Model DF 21

  Class III

  FDA 510(k) K041883 Active Cleared 7 Sep 2004

• Skintact ECG Electrode

  Class II

  FDA 510(k) K040249 Active Cleared 24 Feb 2004

• Skintact Cool Contact Electrosurgical Grounding Plates

  Class II

  FDA 510(k) K030362 Active Cleared 14 Apr 2003

See all devices from Leonhard Lang GmbH →

• Are these electrodes suitable for use with pediatric patients under eight years old or weighing less than 25 kg?

  No, these Skintact Radiotransparent Multifunction Electrodes are explicitly designed for adult and pediatric patients over eight years old or weighing over 25 kg. The manufacturer specifies this weight/age threshold to ensure proper fit, adhesion, and functionality for accurate electrocardiographic monitoring and interventions.

• How are these electrodes supplied, and what should I expect in terms of sterility and reuse?

  The Skintact Radiotransparent Multifunction Electrodes are supplied as non-sterile, single-use devices. This means each electrode is intended for one-time use only, and they should not be reused or reprocessed. The non-sterile designation indicates they are not intended for invasive procedures requiring sterile conditions, but they are designed for reliable adhesion and signal transmission in electrocardiographic and defibrillation applications.

• Can these electrodes be used during radiographic imaging, and how does their design support this?

  Yes, these electrodes are radiolucent, meaning they allow X-ray imaging to pass through without obstruction. This design ensures compatibility with radiographic studies during cardiac interventions, such as defibrillation, pacing, or cardioversion, where real-time imaging may be required while monitoring heart function.

• What type of adhesive is used on these electrodes, and how does it benefit the user?

  The Skintact Radiotransparent Multifunction Electrodes feature an Aqua-Tac solid gel adhesive, which enhances skin adhesion. This adhesive is designed to maintain secure contact with the skin during prolonged monitoring or interventions, reducing the risk of displacement and ensuring consistent signal transmission for accurate electrocardiographic readings.

• What regulatory pathway was followed for the FDA clearance of these electrodes, and what does this imply for their use?

  The Skintact Radiotransparent Multifunction Electrodes received FDA clearance via a 510(k) pathway (K103186) under traditional review, classified under FDA regulation number 870.5310 and reviewed by the Cardiovascular (CV) Advisory Committee. This clearance indicates the device was deemed substantially equivalent to a legally marketed predicate device for cardiovascular applications, including electrocardiographic monitoring, defibrillation, pacing, and cardioversion.