AED BRANDS, LLC

AED Brands, LLC specializes in primary battery-powered automated external defibrillators (AEDs) and single-use electrode conductive skin pads. The AEDs are designed for emergency cardiac response, delivering electrical shocks to restore normal heart rhythm during sudden cardiac arrest. The electrode pads are disposable adhesive pads that attach to a patient’s chest to facilitate shock delivery, ensuring safe and effective use in life-threatening situations.

AED Brands, LLC is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies these devices as Class III, which means they are considered high-risk and require premarket approval before they can be marketed. This classification ensures rigorous evaluation of safety and effectiveness before authorization.

AED Brands, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product code to each device, enabling traceability, better tracking of medical devices in the market, and compliance with U.S. regulatory requirements. This helps ensure transparency and accountability in the supply chain.

AED Brands, LLC’s devices fall under Class III classification by the FDA. This classification is reserved for high-risk medical devices that require a high level of regulatory control to ensure safety and efficacy. Because of this classification, these devices must undergo a premarket approval (PMA) process, which includes extensive clinical trials and review by the FDA before they can be authorized for sale. This stringent process helps mitigate risks associated with life-saving equipment like AEDs.