Skintact, various other tradenames

• • Terminated Z-3109-2017 FDA Class I ·initiated 8 Aug 2017

  Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. This may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.

• • Terminated Z-0004-2017 FDA Class I ·initiated 1 Sep 2016

  There is a risk that defibrillation electrodes model DF29N will be connected with the defibrillator Welch Allyn AED 10 only with delay or not at all. This may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.

510(k) Number

K142803 ↗

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 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

See all devices from Leonhard Lang GmbH →

• Is the Skintact device meant for single-use or can it be reused in multiple emergency situations?

  The Skintact is classified as a reusable Class III device, meaning it is designed for repeated use in emergency settings like pre-hospital and in-hospital environments. Since it is not intended for sterile procedures or implantation, it does not require sterilization between uses, but proper maintenance and cleaning as per manufacturer guidelines are essential to ensure reliable operation.

• What types of environments is the Skintact intended for, and how does it assist untrained responders?

  The Skintact is specifically designed for emergency settings, including both pre-hospital (e.g., ambulance use) and in-hospital environments where cardiac arrest may occur. It features automated voice prompts and shock delivery, guiding untrained responders through CPR and defibrillation procedures to help restore a normal heart rhythm during cardiac emergencies.

• Does the Skintact require special storage conditions, and if so, what are they?

  The Skintact does not specify special storage conditions like temperature or humidity requirements in the provided data. However, as a reusable medical device, it should be stored in a clean, dry environment away from direct sunlight, moisture, and extreme temperatures to maintain its functionality and ensure reliability during emergencies.

• What regulatory pathway was followed for the Skintact’s FDA authorization, and what does that mean for its use?

  The Skintact received FDA authorization through a 510(k) clearance (K142803), which means it was determined to be substantially equivalent to a legally marketed predicate device. This pathway confirms its compliance with FDA standards for Automated External Defibrillators (Non-Wearable) under regulation number 870.5310, ensuring it meets safety and performance requirements for use in emergency cardiac situations.

• Are there multiple models or variants of the Skintact, and how can I identify them?

  Yes, the Skintact has multiple variants, each associated with distinct FEI numbers (e.g., 3026976873, 1218058, etc.) and registration numbers listed in the data. These identifiers help distinguish between different models or configurations, though the core functionality—automated defibrillation with voice guidance—remains consistent across all variants. For precise model details, refer to the manufacturer’s documentation or contact Leonhard Lang GmbH.