The IP has been approved in the USA, China and pending for the EU and rest of the world. The patents for the juice formulations are in the process of being patented for USA and Asia Pacific and for the EU and rest of the world.
Analytical data (i.e. full aerosol size distributions across multiple batches, and delivered dose data across multiple puffs and multiple devices): we have in house data for medication aerosol performance verification and validation test report for the Dolphin. We use the same iQ-100 mesh and technology in the newly modified exterior shells of our new devices. Eighteen (18) test reports were submitted to obtain our 510K for FDA and CE approval.
The factory of manufacture is FDA approved, one of only two in Asia Pacific : GMP, FMEA, strict quality control, CE and 510K approval were obtained for iQ-100 and the series use the same technology with different outer shell designs The same production lines and processes will be followed in the factory for the production of the new series and other products under development.
RoHs and REACH approval obtained for iQ-100 device and materials. The same materials are being used for the new series. RoHs and REACH approval will be obtained similarly prior to mass production.
The mesh plate is made of a unique combination of palladium and alloy nickel in a patented process. This is unique and superior to our competitor’s plastic and stainless steel mesh which breaks down and produces toxic substances over time. Our mesh design and composition are ultrafine, strong and stable.
40 hectare factory facility in Suzhou, China. FDA certified manufacturing facility with ISO 13485, CE 0197, CE 0537 FDA 510K approvals. Three lines currently operation for manufacture with ample space for expansion. Current capacity 100,000 units per month per line. Ready for production immediately