Advanced Ambulatory, Inc.

Advanced Ambulatory, Inc. specializes in circulating-fluid localized thermal therapy systems. These include single-use packs and reusable control units, both designed for procedures that require precise temperature control, such as tissue ablation or localized heating in outpatient or ambulatory care settings.

Advanced Ambulatory, Inc. is based in the United States. Its devices are regulated by the U.S. Food and Drug Administration (FDA) under Class II classification, which applies to devices posing moderate risk and requiring special controls to ensure safety and effectiveness.

Yes, Advanced Ambulatory, Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and trace medical devices throughout their lifecycle, ensuring transparency in the supply chain and regulatory compliance.

Advanced Ambulatory, Inc.’s devices are classified as FDA Class II. This classification is assigned based on the level of risk associated with the device. Class II devices require special controls beyond general controls to mitigate risks, such as those related to thermal therapy, where precise temperature management is critical to patient safety and efficacy.