RE: [MedicaidforHDOT] Re: FDA approved inflatable chamber?

[Guest guest]

Thank you for providing this and it looks like the real thing. However, I

do have a question as to who Dryden is and why is this using an Indiana

address.

Mr. Wicker provided the following websites on the NeuroHBOT list which uses

both New York and California addresses and has no mention of Dryden.

Isn't Dryden the patent holder of the Gamow bag or am I confused?

There is no indication in the letter that this is the actual Oxyhealth

chambers of Samir Patel. Did I miss something?

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI_

_ID=420970

http://www.fda.gov/foi/warning_letters/m3395n.pdf

http://www.fda.gov/foi/warning_letters/m3838n.pdf

There is nothing to show in the 510K that it is the Oxyhealth chamber or did

I miss it. Is Mr. Dryden the owner instead of Mr. Patel?

Samir Patel told me in Florida that they did have a 510k clearance, which is

fine. I had requested a copy from the company and have never recieved it.

Someone later advised me they did not have a clearance, that the one they

were using was actually the Gamow bag which is a totally different chamber.

I would like very much to clear up the confusion on this issue.

Let me state clearly that the inflatable chambers seem to be working well

for those using them and I have not heard of any problems other than an

occasional leaky zipper or, in one case, a sticking zipper, which could

probably be repaired easily enough. There is a big need for this chamber,

especially if it could be approved for 1.5 ATA and 100% oxygen use at home.

Also, I think it is the right of those needing these chambers to purchase

them and use them at home for whatever reason they chose. It may also be

the only way affordable hbot will be available for brain injury. However,

I think it is also their right to know exactly what clearance is in effect

and legal and to make certain they are not being misled. If they are being

misled, would it mean that they could be misled on other issues such as

safety? This concerns me enough that I am playing both sides of the fence

until I understand the confusion.

ly, the only reason a 510k clearance for altitude sickness is important

is because it assures us that the inflatable chamber we purchase has been

tested for safety for that pressure, etc. which gives us some assurance.

OK, does anyone WHO KNOWS the answers have comments? I am not interested

in speculation, arguments for or against the use of the IFU's, arguments on

safety of these chambers, only on the 510K. Only in facts.

thanks

Hartsoe

[MedicaidforHDOT] Re: FDA approved inflatable chamber?

> A quick search on he FDA web site will find the 510(k) clearance for

> the oxyealth chambers which are also known as the 'gamow bag'.

>

> You can view the PDF of the clearance on the FDA web site at

> http://www.fda.gov/cdrh/pdf/k001409.pdf in case you doubt the

> authenticity of this information.

>

> Clearly these 'oxyhealth' chambers are FDA cleared for Acute

> Mountain Sickness (also known as Altitude Sickness).

>

> The FDA clearance number is K001409 issued on August 2, 2000.

>

> The clearance states they are 'Safe and Effective'. It also states

> that the chambers are 'intended' for use in the home, phsician

> office, outdoor, hospital, sub-acute care'.

>

> The chambers are also 'prescription devices'.

>

>

> > Everyone keeps saying the Oxyhealth chambers have a 510K FDA

> clearance for altitude sickness. I hope it does have because they

> have told me it does have.

> >

> > In the meantime if anyone can produce an actual copy of the FDA

> 510K approval, it would be appreciated. I would hate to think we

> have been lied to all this time. So , or anyone else in

> contact with Samir Patel, please see that we get a copy of this

> approval. I was unable to confirm approval with the FDA. All I

> want is to see the actual approval. I think it is owed to all the

> people who have purchased one with this impression as well as those

> who are considering it. After all if it is approved, that means it

> does meet certain safety criteria, if not, we all have room for

> concern.

> >

> > I have been advocating for everyone's rights to purchase and use

> an inflatable at home. I want to feel as though I have not misled

> anyone.

> >

> > Hartsoe

> >

> >

> >

[Guest guest]

>Dear mlv91745 [mlv91745@...],

>

>This 510k is for a company called HTI -

>http://www.bretonindustries.com/hyperbaric_technologies%2C_inc_.htm Not for

>Oxy-health. And it is not " clearly " FDA cleared because it does not spell

>out Oxy-health or Solace or whatever the chamber is called. 510k's are

>issued to specific manufacturers for specific devices.

>

>If you search the FDA website for 510k's, you can type in oxyhealth or a

>persons name and you will not find anything.

>http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

>If you type in under devices the word HYPERBARIC you will get 43 hits - none

>of which are lists the name of Oxy-health, what is that company's name

>anyways?. You will notice that there is a 510k for a gamow bag by Dr. Igor

>Gamow http://spot.colorado.edu/~gamow/research/bag.html. This is not the

>chamber we have been discussing about.

>

>EXAMPLE'S OF NON-CONFUSION: These companies and their 510k's are clear.

> Baromedical SIGMA 3400:

>http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=103666

> Baromedical SIGMA PLUS/MULTIPLACE:

>http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=102177

> Baromedical SIGMA PLUS MONOPLACE:

>http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=99317

> Baromedical SIGMA MP MULTIPLACE:

>http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=77379

> Sechrist Industries 2500e/er:

>http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=79977

> Sechrist Industries 3200p/3200pr:

>http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86680

> Reimers Systems, inc. T CLASS:

>http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=89857

> AND MANY MANY MORE

>

>

>The fact is; we have not seen a 510k for this OXYHEALTH chamber. I don't

>care if someone said it was approved - I would want to see it. And if there

>is one, why is it hidden somewhere? Maybe in other countries it is an ok

>practice to hide or even not have an approval, but here in the US of A we

>want to be sure, and it goes into fair trade. Call me a stupid American -

>but you can't hate me for being sure that I am not buying a product that has

>no legal standing. Hey, maybe I am wrong - but until someone shows me that

>this chamber has it's own 510k I won't believe it until I see it.

>

>ROQUE WICKER, DMT-A, CHT

Mr. Wicker,

I don't believe Oxyhealth is a manufacturer but only a distributor. Could

it be that Oxyhealth distributes/sells the chambers manufactured by the

company called HTI?

If so, is this a violation of federal law?

Could this marketing technique somehow affect safety?

If so, how?

DF

>

> [MedicaidforHDOT] Re: FDA approved inflatable chamber?

>

>A quick search on he FDA web site will find the 510(k) clearance for

>the oxyealth chambers which are also known as the 'gamow bag'.

>

>You can view the PDF of the clearance on the FDA web site at

>http://www.fda.gov/cdrh/pdf/k001409.pdf in case you doubt the

>authenticity of this information.

>

>Clearly these 'oxyhealth' chambers are FDA cleared for Acute

>Mountain Sickness (also known as Altitude Sickness).

>

>The FDA clearance number is K001409 issued on August 2, 2000.

>

>The clearance states they are 'Safe and Effective'. It also states

>that the chambers are 'intended' for use in the home, phsician

>office, outdoor, hospital, sub-acute care'.

>

>The chambers are also 'prescription devices'.

>

>

>> Everyone keeps saying the Oxyhealth chambers have a 510K FDA

>clearance for altitude sickness. I hope it does have because they

>have told me it does have.

>>

>> In the meantime if anyone can produce an actual copy of the FDA

>510K approval, it would be appreciated. I would hate to think we

>have been lied to all this time. So , or anyone else in

>contact with Samir Patel, please see that we get a copy of this

>approval. I was unable to confirm approval with the FDA. All I

>want is to see the actual approval. I think it is owed to all the

>people who have purchased one with this impression as well as those

>who are considering it. After all if it is approved, that means it

>does meet certain safety criteria, if not, we all have room for

>concern.

>>

>> I have been advocating for everyone's rights to purchase and use

>an inflatable at home. I want to feel as though I have not misled

>anyone.

>>

>> Hartsoe

>>

>>

>>

[Guest guest]

Dear mlv91745 [mlv91745@...],

This 510k is for a company called HTI -

http://www.bretonindustries.com/hyperbaric_technologies%2C_inc_.htm Not for

Oxy-health. And it is not " clearly " FDA cleared because it does not spell

out Oxy-health or Solace or whatever the chamber is called. 510k's are

issued to specific manufacturers for specific devices.

If you search the FDA website for 510k's, you can type in oxyhealth or a

persons name and you will not find anything.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

If you type in under devices the word HYPERBARIC you will get 43 hits - none

of which are lists the name of Oxy-health, what is that company's name

anyways?. You will notice that there is a 510k for a gamow bag by Dr. Igor

Gamow http://spot.colorado.edu/~gamow/research/bag.html. This is not the

chamber we have been discussing about.

EXAMPLE'S OF NON-CONFUSION: These companies and their 510k's are clear.

Baromedical SIGMA 3400:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=103666

Baromedical SIGMA PLUS/MULTIPLACE:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=102177

Baromedical SIGMA PLUS MONOPLACE:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=99317

Baromedical SIGMA MP MULTIPLACE:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=77379

Sechrist Industries 2500e/er:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=79977

Sechrist Industries 3200p/3200pr:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86680

Reimers Systems, inc. T CLASS:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=89857

AND MANY MANY MORE

The fact is; we have not seen a 510k for this OXYHEALTH chamber. I don't

care if someone said it was approved - I would want to see it. And if there

is one, why is it hidden somewhere? Maybe in other countries it is an ok

practice to hide or even not have an approval, but here in the US of A we

want to be sure, and it goes into fair trade. Call me a stupid American -

but you can't hate me for being sure that I am not buying a product that has

no legal standing. Hey, maybe I am wrong - but until someone shows me that

this chamber has it's own 510k I won't believe it until I see it.

ROQUE WICKER, DMT-A, CHT

[MedicaidforHDOT] Re: FDA approved inflatable chamber?

A quick search on he FDA web site will find the 510(k) clearance for

the oxyealth chambers which are also known as the 'gamow bag'.

You can view the PDF of the clearance on the FDA web site at

http://www.fda.gov/cdrh/pdf/k001409.pdf in case you doubt the

authenticity of this information.

Clearly these 'oxyhealth' chambers are FDA cleared for Acute

Mountain Sickness (also known as Altitude Sickness).

The FDA clearance number is K001409 issued on August 2, 2000.

The clearance states they are 'Safe and Effective'. It also states

that the chambers are 'intended' for use in the home, phsician

office, outdoor, hospital, sub-acute care'.

The chambers are also 'prescription devices'.

> Everyone keeps saying the Oxyhealth chambers have a 510K FDA

clearance for altitude sickness. I hope it does have because they

have told me it does have.

>

> In the meantime if anyone can produce an actual copy of the FDA

510K approval, it would be appreciated. I would hate to think we

have been lied to all this time. So , or anyone else in

contact with Samir Patel, please see that we get a copy of this

approval. I was unable to confirm approval with the FDA. All I

want is to see the actual approval. I think it is owed to all the

people who have purchased one with this impression as well as those

who are considering it. After all if it is approved, that means it

does meet certain safety criteria, if not, we all have room for

concern.

>

> I have been advocating for everyone's rights to purchase and use

an inflatable at home. I want to feel as though I have not misled

anyone.

>

> Hartsoe

>

>

>