Getting your product through the FDA clearance process, whether it is a 510(K) or a PMA, that is only one part of your problem in assuring that you would be able to market your product in the US. Assuring that your product and/or treatment would have a reimbursement code is as critical to your device’s success as dealing with the FDA. We work to determine which treatment codes your product can fall under as well as determining a strategy for getting a code in the event that your product does not qualify for an existing code.