AVACEN MEDICAL, INC

AVACEN Medical, Inc. specializes in electric pad systems designed for localized-body heating. These devices are primarily intended for therapeutic uses, such as providing pain relief and reducing inflammation. The company’s entire portfolio falls under this category, with no other device types listed.

AVACEN Medical, Inc. is headquartered in the United States. The company’s regulatory and manufacturing operations are conducted within this jurisdiction, which influences its compliance requirements and device listings.

AVACEN Medical, Inc.’s devices are classified under the FDA’s Class II regulatory category. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

Yes, AVACEN Medical, Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This listing ensures traceability and compliance with U.S. medical device regulations, allowing for better tracking of devices throughout their lifecycle.

The FDA’s UDI database is a standardized system that assigns unique identifiers to medical devices to improve tracking, reduce medical errors, and enhance post-market surveillance. Since AVACEN’s devices are listed here, it demonstrates compliance with U.S. regulatory requirements for transparency and accountability in the medical device supply chain.