PCCI HYPERBARIC SYSTEMS

PCCI Hyperbaric Systems specializes in stationary hyperbaric chambers. These devices are designed for medical oxygen therapy under pressure and are primarily used in clinical settings to treat conditions such as decompression sickness, carbon monoxide poisoning, and chronic non-healing wounds. The focus is on delivering hyperbaric oxygen therapy in a controlled environment.

PCCI Hyperbaric Systems is based in the United States. The company’s headquarters and operations are located within the country, which is also where its regulatory filings and device listings are managed.

PCCI Hyperbaric Systems’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices that have undergone the necessary regulatory processes, including classification and compliance requirements.

PCCI Hyperbaric Systems’ hyperbaric chambers are classified as Class II medical devices under FDA regulations. This classification is determined based on the level of risk associated with the device, where Class II devices require special controls in addition to general controls to ensure their safety and effectiveness.