Advisory Notice 4 July 2008 for USA Customers

[Guest guest]

Dear All Customers in the USA:

In the past few months we have been in continual communication with the FDA

regarding the registration and compliance of our device.

As part of our continued communication with the FDA, we have received approval

to reinform the public of the Indications for Use of the EPFX Device, and also

to inform the public and implement a revised Prescription Control for future

sales of the device.

Please see the attached Advisory Notice which is mandatory that all

users of the EPFX in the USA receive and fully understand and implement

in their use of the device. If there are questions on this Advisory Notice, please contact the staff as listed directly on the Advisory Notice. Thank you, LloydQuality System Manager

[Guest guest]

Hello,

I am a bit confused. If a person can only purchase the EPFX with a prescription does it mean that the EPFX cannot be used for business?

Thanks,

Katia

From: Lloyd <lloydqxciscio@...>Subject: Advisory Notice 4 July 2008 for USA Customersqxci-english Date: Friday, July 4, 2008, 11:09 AM

Dear All Customers in the USA:In the past few months we have been in continual communication with the FDA regarding the registration and compliance of our device. As part of our continued communication with the FDA, we have received approval to reinform the public of the Indications for Use of the EPFX Device, and also to inform the public and implement a revised Prescription Control for future sales of the device. Please see the attached Advisory Notice which is mandatory that all users of the EPFX in the USA receive and fully understand and implement in their use of the device.

If there are questions on this Advisory Notice, please contact the staff as listed directly on the Advisory Notice.

Thank you,

LloydQuality System Manager

[Guest guest]

Hello ,how do I access the Advisory notice.I am new to this site Im

kinda lost. Thanks Dan

[Guest guest]

Dear GroupThere were two attachments to that email, but here they are again attached. One is the Advisory Notice and one is the Public Announcement. If you have further questions, please write to Lloyd on richard@.... Thank you,The ModeratorsFrom: dankasey29 <dankasey29@...>Subject: Re: Advisory Notice 4 July 2008 for USA Customersqxci-english Date: Sunday, July 6, 2008, 7:23 PM

Hello ,how do I access the Advisory notice.I am new to this site Im

kinda lost. Thanks Dan

[Guest guest]

Dear Kate and the GroupIf the person uses it for a business, then they must ensure that they have all of the proper requirements for using the device in their business under local and state legislation. Best regards, Lloyd

From: Lloyd <lloydqxciscio>Subject: Advisory Notice 4 July 2008 for USA Customersqxci-englishDate: Friday, July 4, 2008, 11:09 AM

Dear All Customers in the USA:In the past few months we have been in continual communication with the FDA regarding the registration and compliance of our device. As part of our continued communication with the FDA, we have received approval to reinform the public of the Indications for Use of the EPFX Device, and also to inform the public and implement a revised Prescription Control for future sales of the device. Please see the attached Advisory Notice which is mandatory that all users of the EPFX in the USA receive and fully understand and implement in their use of the device.

If there are questions on this Advisory Notice, please contact the staff as listed directly on the Advisory Notice.

Thank you,

LloydQuality System Manager

[Guest guest]

Hi Dan

If you did not have the " message delivery " for your chat selected

as " Individual Delivery " , then you cannot access the files from the

chat messages. It will show as " attachment (not stored) " . I will try to

send them to your personal email.

blessings

haya

[Guest guest]

Greetings,

I am vacationing outside USA and just had a chance to scan messages. I'm surprised by this NOTICE. I do not understand:

1) if this is VOLUNTARY choice by the Eclosion, Budapest, why is it mandatory in USA?

2) plus effective retroactively for me, reading it a few days after it went into effect voluntarily on the major USA holiday; usually NOTICES are given 30 days courtesy time?

3) from the top of my vacationing-head, legally I know I have a right NOT TO SELF INCRIMINATE MYSELF by pleading the 5the Amendment....Would I be wanting to ask for a prescription to work on myself? How far have we regressed?

4) Eclosion, Budapest, needs my permission, as the practitioner, before submitting my name, address, phone or anything else to FDA or violation of my PRIVACY ACT applies!

First the practitioners' list, and then will we be asked to submit the CONFIDENTIAL CLIENTS LIST AND WHAT ELSE?

5) Your response below, , in regard to running a business, stating: "If the person uses it for a business, then they must ensure that they have all of the proper requirements for using the device in their business under local and state legislation", needs legal clarification, as I work globally, live locally and often travel overseas with the device....that's the reason why I chose to get licensed under IMUNE, and not locally or by a state. It was my understanding that IMUNE is PRIVATE INTERNATIONAL INSTITUTION, and if one learns the laws and knows how to apply the private-license, it applies anywhere....

I'll be home in a few days. I am printing out this NOTICE to give more feedback soon.

Olga Nada, OM, LBT, HTC, CBT

From: Lloyd <lloydqxciscio>Subject: Advisory Notice 4 July 2008 for USA Customersqxci-englishDate: Friday, July 4, 2008, 11:09 AM

Dear All Customers in the USA:In the past few months we have been in continual communication with the FDA regarding the registration and compliance of our device. As part of our continued communication with the FDA, we have received approval to reinform the public of the Indications for Use of the EPFX Device, and also to inform the public and implement a revised Prescription Control for future sales of the device. Please see the attached Advisory Notice which is mandatory that all users of the EPFX in the USA receive and fully understand and implement in their use of the device.

If there are questions on this Advisory Notice, please contact the staff as listed directly on the Advisory Notice.

Thank you,

LloydQuality System Manager