FINK ENGINEERING PTY LTD

Fink Engineering Pty Ltd specializes in stationary multiplace hyperbaric oxygen treatment chambers. These devices are designed for medical use in hyperbaric oxygen therapy, allowing multiple patients to receive treatment simultaneously in a controlled environment. The company produces standard models like the Multiplace Hyperbaric Oxygen Treatment Chamber, as well as specialized variants such as the SL8, DL8, TL20, and the FINK Chamber series (FESL, FEDL, FETL).

Fink Engineering Pty Ltd is based in the United States. Its hyperbaric oxygen treatment chambers are specifically designed for use in the U.S. market, where they must comply with FDA regulations for medical devices. The devices are intended for clinical settings where hyperbaric oxygen therapy is administered.

Fink Engineering Pty Ltd’s hyperbaric oxygen treatment chambers are classified as Class II medical devices under FDA regulations. This classification is based on the agency’s risk-based system, where Class II devices generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. The company’s devices are subject to compliance requirements such as 510(k) premarket notifications and UDI labeling.

Fink Engineering Pty Ltd’s hyperbaric oxygen treatment chambers are listed in the FDA’s 510(k) premarket notification database, which documents devices that have been cleared through the 510(k) process. Additionally, the company’s devices are included in the FDA’s Unique Device Identifier (UDI) system, which standardizes identification for medical devices to improve tracking and compliance. These listings reflect the regulatory pathway taken to authorize the devices for use in the U.S.