Important Information for all U.S. AED and Professional Defibrillator Owners
Do you have an AED or professional defibrillator?
If so, effective February 3, 2022: All AEDs and professional defibrillators must be FDA-approved under the premarket approval (PMA) regulation.
What is a premarket approval (PMA)?
Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
Which AEDs & professional defibrillators does this effect?
According to the FDA-Approved AEDs List, the following AEDs and professional defibrillators have been effected:
My AED or professional defibrillator is NOT compliant... Now what?
If any of your AEDs or professional defibrillators are not included on the FDA-approved devices list, contact Rescue Site Services for more information about how you can upgrade to an FDA-approved devices.
Ready to upgrade now?
Visit us online at RescueSiteService.com and purchase your new AED today.