Electrochemical Oxygen Concepts, Inc.

Electrochemical Oxygen Concepts, Inc. specializes in wound therapy devices that deliver oxygen directly to chronic or difficult-to-heal wounds. Their portfolio includes reusable oxygenators, single-use oxygen diffusion dressings (such as the OxySpur® series), humidification packs (like the OxyGeni® Humidicant Pack), tubing, and accessories like cannulas and extension sets. These products are designed to enhance wound healing by providing localized oxygen therapy.

The company is headquartered in the United States. Since it operates within the US market, its devices must comply with FDA regulations. All listed products fall under Class II classification, meaning they require premarket notification (510(k)) submissions and adherence to the FDA’s Unique Device Identification (UDI) system. This classification ensures that devices undergo rigorous review before entering the market.

The company’s devices are registered under the FDA’s 510(k) premarket notification program and the FDA’s Unique Device Identification (UDI) system. These registries ensure that each product has undergone the necessary regulatory review and is traceable through its UDI. The 510(k) process confirms that the devices meet FDA safety and effectiveness standards before commercial distribution.

All of Electrochemical Oxygen Concepts, Inc.’s listed devices fall under Class II classification in the US. This classification is assigned based on the risk level of the device—Class II devices pose moderate risk and require premarket notification (510(k)) submissions to demonstrate substantial equivalence to a legally marketed predicate device. Additionally, compliance with the FDA’s UDI system is mandatory to ensure traceability and regulatory oversight.