We were approached to design a Negative Wound Pressure device to directly compete with smaller battery powered devices. The specifications included fluid level sensors, a long battery life, and a custom LCD.
We developed, with the help of a local electronics engineering supplier, a product that met the companies specifications with the elements that outshine their competition.
We helped take the product through UL 60601 and provided documentation for the DHF, so FDA would be satisfied. As a class 2 device the unit needed a 510K, but with many predicate devices to reference the process went smoothly.
Little did we know, the company we were working with didn't have prior experience with the FDA, resulting in a lack of experience with FDA audits. Some minor issues were found and production was shutdown. Shortly after the company closed Pensar Medical stepped in, purchased the product, and fixed the issues the FDA found. Issues included incorrect cleaning procedures that did not follow the guidelines for continuous product improvement and corrective actions and the updating of the user manual warning customers against using caustic spray cleaners.
We are glad to see that the Pensar Wound Pro is back on the market and we give Pensar credit for their foresight in seeing the value of the product. We were happy to see that they took the initiative to go through the FDA qualification, which will allow them to re-market the product legally.