TZ Medical Adult and Pediatric Multi-Function Defibrillation Electrodes and Adaptors – P200005
This is a brief overview of information related to the FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for the FDA’s approval.
Product Name: TZ Medical Adult Multi-Function Defibrillation Electrodes and Adapters and TZ Medical Pediatric Multi-Function Defibrillation Electrodes and Adapters
PMA Applicant: TZ Medical, Inc
Address: 17750 SW Upper Boones Ferry Road #150, Portland, OR 97224 USA
Approval Date: January 9, 2024
Approval Letter: Approval Order
What is it?
TZ Medical Multi-Function Defibrillation Electrodes and Adaptors monitor the heart’s rhythm and deliver a pacing or electrical shock from a defibrillator (a device that applies an electric charge to the heart to restore a normal heartbeat) to a person with an arrhythmia.
TZ Medical Multi-Function Defibrillation Electrodes stick to a person’s chest and are connected to a compatible defibrillator directly or through a connecting device (adaptor). Once connected, the compatible defibrillator can monitor the person’s heart rhythm to detect and correct a life-threatening arrhythmia and deliver an electrical pulse or shock through the electrodes.
The TZ Medical Multi-Function Defibrillation Electrodes are indicated for use by trained first responders with compatible defibrillators to treat abnormal heart rhythms, including:
• Ventricular fibrillation (VF)
• Ventricular tachycardia (VT)
• Bradycardia (heart beats too slow)
Different models of the electrodes are indicated for use with either automated external defibrillators (AEDs), which are designed to be used by anyone with minimal training, or manual defibrillators, which are designed to be used by trained medical professionals.
When connected to a compatible defibrillator, TZ Medical Multi-Function Defibrillator Electrodes and Adaptors can reduce the time a person is in cardiac arrest and increase the chance for survival.
This device does not have specific situations when it should not be used (contraindications).