Is your AED FDA approved?

On February 3rd 2022 several AED models lost their FDA approval. Is your AED on this list?

Non FDA Approved AED’s
Cardiac Science 9200 Physio-Control Lifepak 12
Heartsine 300P Physio-Control Lifepak 20
Philips FR2/FR2+ Physio-Control Lifepak 500
Philips Forerunner Welch Allyn AED 10
Philips Heartstart XL Zoll M Series Defibrillator
Philips Heartstart MRx Zoll E Series Defibrillator

What this means if your AED is on this list … You will no longer be able to purchase replacement pads or batteries for your AED. The manufacturer will no longer provide support for it.

What you need to do next … You will need to replace your AED. You don’t need to replace it immediately, but you’ll need to do so before the pads or batteries reach their expiration date.
If you are in the State of New Hampshire please contact the NH AED Direct Purchase Program for purchasing information. The NH program is offering several brands of AED’s for a discounted price.
If you are not in New Hampshire please contact us for AED purchase options. We have partnerships with AED vendors and are often able to pass along those savings to you.

My AED is not on your list, is it okay? Yes! But you can also view the list of FDA Approved AED’s.

Why are some AED’s no longer approved? In 2015 the FDA published an order requiring manufacturers to file premarket approvals (PMA) for all AED’s and related supplies within 90 days. However they did not intend to enforce this for 60 months after the final order. The order went into effect on February 3, 2020 and the deadline for manufacturer’s to file their PMA was further extended due to the pandemic to February 3, 2022.

You can read the full information on the FDA AED webpage.

Is your AED FDA approved?
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