Skintact and Various Other Tradenames

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

510(k) Number

K073104 ↗

FDA Product Code

DRX

Device Class

Class II

Regulation

21 CFR Part 870.2360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Skintact

  Class I

  CE/MDR

• megro

  Class I

  CE/MDR

• Skintact Radiotransparent Multifunction Electrodes

  Class III

  FDA 510(k) K103186 Active Cleared 8 Feb 2011

• 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 →

• What are Skintact electrode systems used for?

  Skintact electrode systems are medical devices designed for ECG, defibrillation, electrosurgery and stimulation applications. They are manufactured by Leonhard Lang GmbH and available under various tradenames including Skintact.

• Are Skintact electrode systems reusable or single-use?

  Skintact electrode systems are supplied as single-use devices and are not MRI compatible. They should be discarded after a single use to ensure optimal performance and patient safety.

• What sizes are available for Skintact electrode systems?

  Skintact electrode systems are available in various sizes including KH06D. The specific size requirements should be selected based on the clinical application and patient needs.

• How should Skintact electrode systems be stored?

  Skintact electrode systems should be stored at room temperature to maintain their integrity and functionality. Proper storage conditions help ensure the devices perform as intended during clinical use.

• What is the regulatory status of Skintact electrode systems?

  Skintact electrode systems are authorized under FDA 510(k) clearance with number K073104 and product code DRX. They have been determined to be substantially equivalent to predicate devices for their intended uses.