Good News!!HOMED Medical's Portable Oxygen Concentrator Have Successfully Obtained U.S. FDA 510(k) Market Access Approval !
date : 2026-01-24
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HOMED Medical's independently developed portable oxygen concentrator has officially received a 510(k) marketing authorization letter issued by the U.S. Food and Drug Administration (FDA)! This is not merely an authorization letter, but a “passport” to global high-standard medical markets, signifying that China's intelligent manufacturing has gained international recognition in the field of respiratory health.

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This admission that our products fully meet the FDA's stringent requirements in safety, efficacy, stability, and quality control systems. FDA 510(k) certification is renowned for its globally recognized authority. Obtaining this license is the highest recognition of HOMED Medical's years of deep research and development, as well as its lean manufacturing capabilities.. HOMED portable oxygen concentrators will deliver exceptional performance and reliable quality, providing lightweight, efficient, and long-lasting oxygen support to users across the United States and worldwide. This enables individuals with chronic respiratory conditions, the elderly, and high-altitude travelers to break free from spatial constraints and embrace a more liberated and proactive approach to health and well-being.

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This marks not only the successful global expansion of our products but also a significant step in HOMED's mission “Technology Protects Respiratory Health ”We remain committed to integrating cutting-edge technology into health management, bringing professional medical devices into homes and daily life. This breakthrough has opened broader international horizons and collaboration channels for us. Moving forward, HOMED will continue investing in R&D, enriching our product portfolio, and serving the global market with more diverse and intelligent health solutions.

We extend our gratitude to every partner and user for their trust. Moving forward,HOMED will steadfastly uphold its mission: to ensure every breath is filled with strength and freedom!

#HOMED Medical #FDA510K #Medical Globalization #Chinese Smart Manufacturing  #Portable Oxygen Concentrator #Respiratory Health #Innovative Technology #Global Certification