Avive Solutions, Inc.

Avive Solutions, Inc. specializes in rechargeable public automated external defibrillators (AEDs). These include standalone AED units, systems with disposable electrode pads (like the Avive Pad Cartridge), and advanced models with connectivity features (such as the Avive AED with Avive Connect). Their devices are designed for public use in emergency response scenarios, ensuring accessibility in non-clinical settings like workplaces, public transit, or community spaces.

Avive Solutions, Inc. is based in the United States. Its devices are intended for commercial distribution within the US regulatory framework, where they undergo evaluation under FDA requirements. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, reflecting compliance with US medical device regulations.

Avive Solutions’ devices are classified as Class III under US regulations. This classification applies to devices that support or sustain life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices require premarket approval (PMA) from the FDA, a rigorous review process to ensure safety and effectiveness before commercialization.

Avive Solutions’ devices are listed in the FDA’s Premarket Approval (PMA) database and the FDA’s Unique Device Identifier (UDI) system. The PMA listing confirms the device has undergone FDA review and approval, while the UDI database provides standardized identification for tracking and compliance purposes in the US market.

Avive’s AEDs fall under Class III classification because they are critical for life-saving interventions in emergencies. The FDA reserves this classification for devices that pose higher risks if they fail or malfunction, such as those used in cardiac arrest situations. PMA ensures these devices undergo comprehensive clinical testing and validation to confirm their safety, performance, and effectiveness before public use, aligning with the high-stakes nature of their intended application.