The submission can be checked on the official website! The link is as follows:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240774
·Highly customizable: appearance, color, dosage, scale customizable.
·Current smallest is 0.75 units (0.0075mL) and the injection range covers 60 / 74/ 80 units; can develop according to different indications.
·Pressing force: 80 units <15N, 60 units <8N, accurate dosage, professional R&D team and data validation information support.
·Successfully obtained Class II medical device license; CE MDR, FDA (510k) has been submitted for review.
·Used for long-term injection of insulin and other drugs.
Simple operation
It is easy for beginners to use, eliminating the need for professional guidance.
Reusable Pen Injector Customization Solution