Guest guest Posted February 9, 2008 Report Share Posted February 9, 2008 Hi . Please advise the link u refered to, on the FDA site,has no mention of anything close to the EPFX.(it mentions Latex Gloves...). The things i found regarding the device r: 1. Adverse Event Report (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM ?MDRFOI__ID=886687) 2.An import alert(kind of). (http://www.fda.gov/ora/fiars/ora_import_ia8006.html). Can u,please,double check the link? It will be very helpful... 10x a lot Vered Shay > oh yes it is > http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm? ID=71067 > > > > 510(k) Premarket Notification Database > Device Classification Name > device, biofeedback > > 510(k) Number > K892114 > > Device Name > ELECTRO-PHYSIO-FEEDBACK-XRROID* SYSTEM > > Applicant > ECLOSION, INC. > > 3960-a niagara st. > > denver, CO 80207 > > > > > > > Regulation Number > 882.5050 > > Classification Product Code > HCC > > > > Date Received > 03/30/1989 > > Decision Date > 10/13/1989 > > Decision > substantially equivalent (SE) > > Classification Advisory Committee > Neurology > > Review Advisory Committee > Neurology > > Statement/Summary/Purged Status > Purged, no summary or statement > > Type > Traditional > > Reviewed by Third Party > No > > Expedited Review > > > > > > > > > > > > Dr Kelsey PhD, N.D. > see www.qxcisynergy.co.uk for Tech Info, Manuals, Accessories > T:+44 (0)121 243 6318 > F: +44 (0)870 460 1138 > Re: Panic or Protect Yourself-- It's Your Choice > > > I searched for the FDA (K 892114) registration information and is NOT > on the FDA website list of registered devices. The EPFX is not > anywhere on the FDA list of registed devices. > > --- > . > > > > ------------------------------------------------------------------- ----------- > > > No virus found in this incoming message. > Checked by AVG Free Edition. > Version: 7.5.516 / Virus Database: 269.19.9/1238 - Release Date: 1/22/2008 20:12 > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 22, 2008 Report Share Posted February 22, 2008 use the link put eclosion in the applicant field and hit search Dr Kelsey PhD, N.D. Imune- Vice Chancellor info@...www.imune.netF: +44 870 460 1138T: +44 121 243 6318 Re: Panic or Protect Yourself-- It's Your Choice> > > I searched for the FDA (K 892114) registration information and is NOT > on the FDA website list of registered devices. The EPFX is not > anywhere on the FDA list of registed devices. > > --- > . > > > > ---------------------------------------------------------------------> > > No virus found in this incoming message.> Checked by AVG Free Edition. > Version: 7.5.516 / Virus Database: 269.19.9/1238 - Release Date: 1/22/2008 20:12> No virus found in this incoming message.Checked by AVG Free Edition. Version: 7.5.516 / Virus Database: 269.20.9/1292 - Release Date: 2/21/2008 16:09 Quote Link to comment Share on other sites More sharing options...
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