Refusal Actions by FDA as Recorded in OASIS for Hungary

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason


    Eclosion KFT.
    Budapest , HU 1089                             NOL-DO  112-0879907-5/1/1
    84H--CC   791463523390  E.P.F.X. BIOFEEDBACK DEVICE
                        11-JAN-2008                        RXPERSONAL
                                                           NO 510(K)