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  #1 (permalink)  
Old 13-04-2008, 09:10 PM
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Join Date: Aug 2007
Posts: 8
Thumbs down FDA to Ban QXCI

Does anyone know any more, I have just seen this:
FDA Urged to Curb Bogus "Energy Medicine" Devices
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  #2 (permalink)  
Old 01-05-2008, 03:21 PM
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Join Date: May 2008
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Hmmm, just understand the part that FDA banned fake energy medicine devices.
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  #3 (permalink)  
Old 01-05-2008, 03:36 PM
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Join Date: Apr 2007
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PUBLIC STATEMENT

Date: 10 April 2008

From: Richard Lloyd, Office Manager

To: all interested parties

Re: Public Statement from the Budapest Home Office regarding recent issues



This is a Public Statement that follows the issues addressed on the Public Statement 16 January 2008.

Since December 2007, we have had direct contact with the FDA regarding issues surrounding the intended use of our EPFX device in the United States. Since that time we have had numerous steps in a Corrective Action Plan (CAP) with the FDA with the goal of maintaining compliance to our FDA Registration. I wish to inform you that today I have submitted CAP #4 to the FDA and am now waiting for a response from our contact at the FDA. It is impossible to say how long it may take the FDA to review CAP #4 but as soon as they respond then we will follow through with the necessary actions in their request to continue with this CAP process as swiftly as possible.

The goal in going through the CAP process is that we will again be permitted to import the EPFX into the USA. Please keep in mind that from 20 December 2007, we have voluntarily stopped shipping the EPFX into the USA until such time that the CAP process could be initiated. Shortly thereafter on 4 January 2008, the FDA have initiated an Import Alert which means that the device cannot be imported into the USA. This is a standard part of the CAP process as the FDA do not permit devices to enter the USA until the CAP process is complete.

As you can imagine, this is a lengthy process and we ask for your patience and understanding as we do our best to complete the CAP process.

Customers who currently own and use an EPFX Device are not affected by this Import Alert and we will continue to offer the best support and service through our endorsed Brokers.

In regards to the proper use and registration of the device, there is a lot of legal and contractual wording that is very important to understand. Newspaper articles, chat and e-mail groups, and online journals often times do not pay careful attention to the correct wording and understanding of the greater situation. We are currently working with Brokers/Networkers to improve the training and education that is required for the use of the EPFX. Please keep in contact with your Broker/Networker for the latest seminar/training in your area.

There are a lot of issues surrounding the recent media and the whirlwind of rumors and misinformation that has come of it. I am more than happy to clarify and explain the situation if you write an e-mail to me on Richard@eclosion- epfx.com. However, please keep in mind that the number of e-mails has increased in the past few weeks and my CAP with the FDA is a multi-step process under strict deadlines and sometimes I have to concentrate on the next step in the CAP. However, I will do my best to respond to your e-mail or I may forward it to some of the staff in the Budapest Home Office who can help you.

A good opportunity to meet with the Budapest Home Office and to learn more about the device is at the Budapest World Conference. Please check the conference website www.qxconference. com for more information. The Conference is always held at the Budapest WestEnd Hilton in the middle of October and this year will be 17-20 October 2008 (Friday to Monday inclusive).

Thank you for your understanding and patience.
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