Cranial Remolding in Salt Lake City, Utah
In early 1997, Fit-Well began the process of preparing for F.D.A. clearance. There were many hurdles to overcome in order to be cleared by the F.D.A., such as providing results that the proprietary transparent thermoplastic material used to manufacture the P.A.P. was safe and would not cause any reaction when used next to the skin. Also proving the safety and effectiveness to the patient and that the P.A.P. actually corrects the misshaped cranium of infants. There were 195 infant cases that provided the information regarding the safety and effectiveness of the P.A.P. Orthosis, which began the F.D.A. process. As of January 2002, Fit-Well received the Food and Drug Administration clearance for the P.A.P. Orthosis.