epliepsy bed alarm emfit alarm update

[Guest guest]

Hello!

As most of you know, Emfit has been on an up-hill struggle with the

FDA for over a year in an attempt to obtain clearance to market our

Epileptic Seizure Alarm in the United States. Unfortunately, we

were not able to succeed due to certain concerns regarding how these

types of products should be regulated in the United States.

It is important that you know that the FDA has not yet determined

exactly what is required for approval of epileptic seizure alarm

products, and as a result there are currently NO FDA-approved

seizure alarms available, despite claims that have been made from

manufacturers in and outside of the U.S. We pride ourselves on our

integrity and will only follow the legal route when it comes to

distributing any of our devices. While this may mean a loss of

sales, we are still morally obligated to our customers.

Our products have been tried and tested throughout Europe and

Australia for over 5 years and we are confident that you will be

equally satisfied with our new motion monitor we are about to

legally introduce into the United States within the next two weeks.

For the FDA approval reasons above, this monitor will not be

intended for, or labeled specifically for, any particular medical

use (for example, as an epilepsy alarm) but instead, will be sold as

a consumer nighttime motion detector for any type of sustained

nighttime movement. The price will remain a reasonable $850.00,

plus shipping and handling, and will include our proprietary,

patented, ultra-responsive movement detection sensor, and control

unit with volume adjustment and pre-set delay (see below).

We will be accepting Visa, MasterCard, PayPal, and Money Orders, and

you may buy directly from us or purchase from our online store at

www.emfit.com . We will be accepting pre-orders, but will not

charge any credit card until the product is ready to ship to you.

Unfortunately, insurance will not be able to cover this new system

for the simple fact that we cannot list or label it as a medical

device. The product comes with a great warranty and a 30-day money-

back guarantee in case you are not completely satisfied with its

performance.

Please do not hesitate to contact me with any questions. I look

forward to (at long last) bringing peace of mind to everyone who has

been waiting for a system such as ours.

[Guest guest]

850 seems a little steep for something like this, especially when there is no

insurance coverage. Also where can one find the studies that have been done

showing it's effectiveness.

Thanks,

-------------- Original message --------------

From: " " <mrefus@...>

Hello!

As most of you know, Emfit has been on an up-hill struggle with the

FDA for over a year in an attempt to obtain clearance to market our

Epileptic Seizure Alarm in the United States. Unfortunately, we

were not able to succeed due to certain concerns regarding how these

types of products should be regulated in the United States.

It is important that you know that the FDA has not yet determined

exactly what is required for approval of epileptic seizure alarm

products, and as a result there are currently NO FDA-approved

seizure alarms available, despite claims that have been made from

manufacturers in and outside of the U.S. We pride ourselves on our

integrity and will only follow the legal route when it comes to

distributing any of our devices. While this may mean a loss of

sales, we are still morally obligated to our customers.

Our products have been tried and tested throughout Europe and

Australia for over 5 years and we are confident that you will be

equally satisfied with our new motion monitor we are about to

legally introduce into the United States within the next two weeks.

For the FDA approval reasons above, this monitor will not be

intended for, or labeled specifically for, any particular medical

use (for example, as an epilepsy alarm) but instead, will be sold as

a consumer nighttime motion detector for any type of sustained

nighttime movement. The price will remain a reasonable $850.00,

plus shipping and handling, and will include our proprietary,

patented, ultra-responsive movement detection sensor, and control

unit with volume adjustment and pre-set delay (see below).

We will be accepting Visa, MasterCard, PayPal, and Money Orders, and

you may buy directly from us or purchase from our online store at

www.emfit.com . We will be accepting pre-orders, but will not

charge any credit card until the product is ready to ship to you.

Unfortunately, insurance will not be able to cover this new system

for the simple fact that we cannot list or label it as a medical

device. The product comes with a great warranty and a 30-day money-

back guarantee in case you are not completely satisfied with its

performance.

Please do not hesitate to contact me with any questions. I look

forward to (at long last) bringing peace of mind to everyone who has

been waiting for a system such as ours.

[Guest guest]

I was on their mailing list so don't know much more. I

just wanted to forward on. Is there a heart monitor we

can use that is sleep friendly? TIA,

--- jpnaleid@... wrote:

> 850 seems a little steep for something like this,

> especially when there is no insurance coverage.

> Also where can one find the studies that have been

> done showing it's effectiveness.

>

> Thanks,

>

>

>

> -------------- Original message --------------

> From: " " <mrefus@...>

> Hello!

>

> As most of you know, Emfit has been on an up-hill

> struggle with the

> FDA for over a year in an attempt to obtain

> clearance to market our

> Epileptic Seizure Alarm in the United States.

> Unfortunately, we

> were not able to succeed due to certain concerns

> regarding how these

> types of products should be regulated in the United

> States.

>

> It is important that you know that the FDA has not

> yet determined

> exactly what is required for approval of epileptic

> seizure alarm

> products, and as a result there are currently NO

> FDA-approved

> seizure alarms available, despite claims that have

> been made from

> manufacturers in and outside of the U.S. We pride

> ourselves on our

> integrity and will only follow the legal route when

> it comes to

> distributing any of our devices. While this may mean

> a loss of

> sales, we are still morally obligated to our

> customers.

>

> Our products have been tried and tested throughout

> Europe and

> Australia for over 5 years and we are confident that

> you will be

> equally satisfied with our new motion monitor we are

> about to

> legally introduce into the United States within the

> next two weeks.

> For the FDA approval reasons above, this monitor

> will not be

> intended for, or labeled specifically for, any

> particular medical

> use (for example, as an epilepsy alarm) but instead,

> will be sold as

> a consumer nighttime motion detector for any type of

> sustained

> nighttime movement. The price will remain a

> reasonable $850.00,

> plus shipping and handling, and will include our

> proprietary,

> patented, ultra-responsive movement detection

> sensor, and control

> unit with volume adjustment and pre-set delay (see

> below).

>

> We will be accepting Visa, MasterCard, PayPal, and

> Money Orders, and

> you may buy directly from us or purchase from our

> online store at

> www.emfit.com . We will be accepting pre-orders, but

> will not

> charge any credit card until the product is ready to

> ship to you.

> Unfortunately, insurance will not be able to cover

> this new system

> for the simple fact that we cannot list or label it

> as a medical

> device. The product comes with a great warranty and

> a 30-day money-

> back guarantee in case you are not completely

> satisfied with its

> performance.

>

> Please do not hesitate to contact me with any

> questions. I look

> forward to (at long last) bringing peace of mind to

> everyone who has

> been waiting for a system such as ours.

>

>

>

>

> [Non-text portions of this message have been

> removed]

>

>

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