MEKICS Accelerates Global Strategy for OmniOx Respiratory Devices
Receives U.S. FDA Clearance and Completes Japan PMDA Registration – Official Entry into North American and Japanese Markets

 

MEKICS Co., Ltd. (CEO JC Kim), a specialized medical device company focused on ventilators and respiratory care systems, announced on the 19th that its high-performance respiratory care product line, the OmniOx series, has obtained official clearance from the U.S. Food and Drug Administration (FDA) and completed registration with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), accelerating its global market expansion.

 

The FDA-cleared product, HFT-750U, is a hospital-grade, high-performance respiratory care device. It integrates multiple functions including High-Flow Nasal Cannula (HFNC), Continuous Positive Airway Pressure (CPAP), and Bi-Level support, forming a versatile respiratory platform. Notably, MEKICS successfully navigated the FDA’s increasingly rigorous clinical and technical requirements for respiratory devices, thanks to its advanced flow and pressure control technology, infection prevention design, and intuitive user interface.

 

The HFT-750U supports various therapy modes, making it highly adaptable across intensive care units (ICUs), emergency departments, and general wards. Its built-in battery enables uninterrupted treatment during intra-hospital transport or procedures such as imaging and minor interventions.

 

The products registered with Japan’s PMDA include the hospital-use HFT-750 and the home-use HFT-751, developed to meet the rising demand for home respiratory care in Japan's aging society. The HFT-751 is designed with an intuitive interface, automatic flow and humidity control, and a comprehensive alarm system—ensuring safe operation even by non-professionals, thus enhancing its competitiveness in the home care market.
 

This Japanese registration recognizes not only the main devices but also the technological completeness of the dedicated OmniOx accessories and consumables. Based on this, MEKICS expects to increase demand for consumables and establish a stable revenue structure in the Japanese market.

Targeting major global markets, including the U.S. and Japan, MEKICS plans to pursue an integrated strategy that includes:

• Expanding partnerships with healthcare institutions

• Establishing robust consumables supply chains

• Operating technical support and education programs

JC Kim, CEO of MEKICS, stated, “The FDA clearance and PMDA registration are further validation of our technological innovation and clinical efficacy on a global level,” adding, “We will continue to set new standards in the global medical device market with the OmniOx series as a technology that protects lives.”