The IP has been approved in the USA, China and pending for the EU and rest of the world in the name of e nicotine systems Asia. The patents for the juice formulations are in the process of being patented and will belong to eNicotine Systems Asia Ltd. (ENSA) for USA and Asia Pacific and for the EU and rest of the world. ENSA have an exclusive license agreement with Health & Life to use their 510 K approved HL-100 Patent US 7,607,589 B2 “Droplet Generation Apparatus” for the e8000 and e8000-2 series products and any future products currently under development.
Analytical data (i.e. full aerosol size distributions across multiple batches, and delivered dose data across multiple puffs and multiple devices): ENSA, H&L have in house data for medication aerosol performance verification and validation test report for HL-100. We use the same HL-100 mesh and technology in the newly modified exterior shell of e8000 and e8000-2. 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 HL-100 and the e8000 and e8000-2 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 e8000 and e8000-2 and other products under development. Stock exchange listed company, www.healthandlife.com.tw
RoHs and REACH approval obtained for HL-100 device and materials. The same materials are being used for e8000 and e8000-2. 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