Joytech's NB-1100 Series Compressor Nebulizers Achieve FDA 510(k) Clearance Under Product Code CAF

We are pleased to announce that our compressor nebulizer models — NB-1100, NB-1101, NB-1102, and NB-1103 — have officially received FDA 510(k) clearance under Product Code CAF.

This clearance demonstrates compliance with stringent U.S. regulatory requirements, confirming that our devices are substantially equivalent in safety and effectiveness to legally marketed products in the United States.

The NB-1100 series is purpose-built to deliver reliable respiratory therapy and undergoes extensive performance testing to ensure consistent aerosol output and stable nebulization rates. This helps medication effectively reach the lower respiratory tract for better treatment outcomes.

Patient safety is central to our mission. All materials in contact with medication or patients are subjected to rigorous biocompatibility assessments, ensuring comfort and safety. Additionally, our nebulizers undergo testing for electrical safety and electromagnetic compatibility, ensuring dependable operation in both clinical and home settings.

We understand the importance of hygiene. The NB-1100 series has been validated for effective cleaning and disinfection processes, maintaining reliable performance without compromise.

Achieving FDA 510(k) clearance under Product Code CAF enables the NB-1100 series to enter global markets, giving our partners and users worldwide confidence in trusted quality, compliance, and peace of mind.

Trust in every breath—with the Joytech NB-1100 Series.