FDA-cleared, clinically proven
All InControl Medical devices are made at our Brookfield, Wisconsin facility. The devices are comprised of medical-grade silicone – a material that can be safely used in contact with living tissue. It is also easily cleaned with soap and water.
All materials and components used in the devices are sourced in the US, with many of our suppliers located within an hour’s driving distance from the factory.
Each device rigorously tested
Our technicians assemble each device by hand; as part of our rigorous quality control process, each device is inspected and/or tested at each stage of the manufacturing process.
Each Apex®M, Apex®, InTone®, InTone®MV, and Intensity® device is leak-tested – with current testing showing a less than 1% failure rate. All failed mechanisms are scrapped, rather than re-worked.
In conformance with FDA regulations, each device has a unique Device ID. Using this ID, we can track each and every component that makes up the device – for 100% traceability and ultimate peace of mind and safety.