Refusal Actions by FDA as Recorded in OASIS for Estonia

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


    Wellspa
    Raplamaa , EE 78203                            MIN-DO  H42-0094009-0/1/1A
    53YY-99   Feng Shui Spa 2G machines - SG20801/2...
                        28-APR-2008                        NO 510(K)