Skintact Multifunction Electrodes, Model DF 21

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

510(k) Number

K041883 ↗

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 Radiotransparent Multifunction Electrodes

  Class III

  FDA 510(k) K103186 Active Cleared 8 Feb 2011

• 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 intended for single-use or can they be reused in clinical settings?

  The Skintact Multifunction Electrodes, Model DF 21, are explicitly designed as reusable devices. They must be cleaned and stored according to the manufacturer’s instructions between uses to maintain performance and sterility, ensuring reliable skin contact for electrocardiographic monitoring, defibrillation, and other electrotherapeutic procedures in clinical settings like cardiac care units or emergency response.

• What types of procedures or applications are these electrodes primarily used for?

  These electrodes are designed for cardiovascular applications, including electrocardiographic monitoring and electrotherapeutic procedures, such as defibrillation. They establish reliable skin contact for electrical signal transmission or delivery, making them suitable for use in automated external defibrillation systems and cardiac care environments.

• How should these electrodes be stored to maintain their performance and sterility between uses?

  Since these are reusable, the manufacturer specifies that they must be cleaned and stored according to their instructions to preserve performance and sterility. Proper storage ensures the adhesive and conductive properties remain intact for repeated clinical use, particularly in settings like emergency response or cardiac care units.

• Are there different sizes or models available for the Skintact Multifunction Electrodes?

  The provided data only references Model DF 21, which is a reusable adhesive electrode designed for cardiovascular applications. While the specifications do not list additional sizes or models in this dataset, the product is categorized under FDA product code MKJ and regulation 870.5310, which may imply compatibility with standard electrode sizes used in defibrillation and monitoring systems. For exact sizing details, refer to the manufacturer’s documentation.