Identity
- Trade Name
- LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger FDA PMA
- Generic Name
- Automated external defibrillators (non-wearable) FDA PMA
Identifiers
- PMA Number
- P160012 FDA PMA
- FDA Product Code
- MKJ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 870.5310 FDA PMA
- Regulation Number
- 870.5310 FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The QUIK-PAK Electrodes are disposable adhesive pads designed for use with automated external defibrillators (non-wearable). These electrodes facilitate the delivery of electrical shocks to restore normal heart rhythm in patients experiencing cardiac arrest, adhering to the classification of defibrillation pads as defined by regulatory authorities.
These electrodes are intended for single-use and are supplied sterile, packaged for immediate clinical application. They are approved for use with specific defibrillator models, including the LIFEPAK CR Plus and LIFEPAK EXPRESS, and are authorized under an FDA Premarket Approval (PMA). The electrodes are sized for adult and pediatric patients aged eight years or older, or weighing more than 25 kg, with reduced-energy variants available for younger children or smaller patients. Storage and handling must comply with sterile medical device protocols.
Frequently asked questions
Are the QUIK-PAK Electrodes suitable for use on infants or very young children, and if so, what special considerations apply?
The QUIK-PAK Electrodes are designed for adults and pediatric patients aged eight years or older, or weighing more than 25 kg. For younger children or smaller patients under these criteria, Physio-Control offers **Infant/Child Reduced Energy Defibrillation Electrodes**, which are specifically designed to deliver lower-energy shocks. These reduced-energy variants ensure safety and effectiveness for pediatric use, as the standard QUIK-PAK Electrodes are not intended for infants or children under eight years or under 25 kg.
How should the QUIK-PAK Electrodes be stored, and what precautions should be taken to maintain their sterility?
The QUIK-PAK Electrodes are supplied **sterile** and packaged for immediate clinical use. Storage must comply with standard sterile medical device protocols to preserve sterility. This includes keeping them in their original, unopened packaging, away from direct sunlight, extreme temperatures, and contamination sources. Always follow manufacturer guidelines for shelf-life and expiration dates to ensure optimal performance and safety.
Can these electrodes be reused, or are they intended for single-use only?
The QUIK-PAK Electrodes are explicitly designed for **single-use only**. Reuse is not recommended or supported by the manufacturer, as this could compromise their performance, sterility, and effectiveness in delivering defibrillation shocks. Adhering to single-use guidelines ensures patient safety and compliance with regulatory standards.
Which defibrillator models are compatible with the QUIK-PAK Electrodes, and are there any limitations on their use?
The QUIK-PAK Electrodes are **authorized for use exclusively with the LIFEPAK CR Plus Defibrillator, LIFEPAK EXPRESS Defibrillator, and CHARGE-PAK Battery Charger**. They are not intended for use with other defibrillator models. Additionally, these electrodes are approved for patients in cardiac arrest who are unresponsive, not breathing normally, and showing no signs of circulation, as defined by the defibrillator’s indications. Proper training in basic life support or advanced emergency response is required for safe operation.
What size options are available for the QUIK-PAK Electrodes, and how do they differ for adult versus pediatric patients?
The QUIK-PAK Electrodes are available in standard sizes for **adult and pediatric patients aged eight years or older, or weighing more than 25 kg**. For younger children or smaller patients under these criteria, **reduced-energy variants** are provided to ensure appropriate shock delivery. The standard electrodes are not sized for infants or children under eight years or under 25 kg, as their physiology requires lower-energy defibrillation to avoid complications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P160012 | Class III | Active |
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Manufacturer
- Manufacturer
- PHYSIO-CONTROL, Inc.
Sources (1)
- FDA PMA P160012 24 fields · synced Sep 18, 2026