Oxy Health Chambers DO have 510(k)

[Guest guest]

A 510(k) can cover several chambers. If you look at the

clearance for the portables, you will note that for the one

clearance number, there are SEVERAL chambers listed.

http://www.fda.gov/cdrh/pdf/k001409.pdf

Ok, now folow carefully..... look at the 510(k) and look in the

device description. IT LISTS SEVERAL MODELS! Wow so that means you

do not need a separate number for each chamber.

So folks, the sky is not falling. The big bad wolf is not about to

blow down the house and we all need to get back to reality!

> , since they are not the manufacturer, who is? Who can I

contact at

> the manufacturer to find the 510K?

> Are you aware that the FDA requires a 510k for each different

product so

> that means we need three 510K numbers, does it not? I am glad

you have

> cleared this up, now if you will just get me a contact person at

the

> manufacturer so I can call them and give them my fax number or get

the 510

> numbers from them so I can get a copy from the FDA.

>

> I really appreciate this, , I knew you would not want all

these parents

> to be in the dark about this. You can email me privately with

their name

> and phone number if you would rather not post it on the list. I

can get

> the 510K numbers tomorrow and we can get this all cleared up so

business can

> be back to normal as usual. I have 3 emails right now on which

is the best

> IFU to buy from interested parents. I will be able to verify

everything is

> OK and they can call Oxyhealth if they want to. Or they can call

the other

> company who does not have a 510K and was upfront about it.

>

> Thanks, . I am sure everyone will be happy to hear the

answers

> tomorrow since you are helping to clear up this mystery.

>

> Now I feel better.

> Hartsoe

>

> Re: [MedicaidforHDOT] No 510K clearance

>

>

> > >a 510k number for any product that Oxy Health manufactures

> >

> >

> > --as Mr. Wicker posted earlier, OxyHealth is not the

manufacturer.

> >

> >

> >

> >

> > >Well I have done search after search on the website at

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

> > >and there are NO 510K documents of any type for Oxy Health

Corporation or

> > >for Samir Patel or for either of the 3 chambers they market.

> NONE!!!!

> > >

> > >So, Dr. Fojgel, , and anyone else who has the info, please

provide

> me

> > >with a 510k number for any product that Oxy Health

manufactures. Since

> > >all of you have seen these and know they exist, you should have

no

> problem

> > >providing this information to this group. Just a simple

number is all

> I

> > >have ever asked for. This is public information according to

the

> freedom

> > >of information act. I have been on the phone with the FDA and

they have

> > >not been able to provide me with anything. They are going to

research it

> > >further for me but I doubt anything will be found. It is

interesting to

> > >note that I can get this information for any of the other

manufacturers

> > >for any particular chamber they offer. If you do a search for

the

> Solace

> > >you will get Latex gloves.

> > >

> > >What does this prove? It proves that someone is lying or

being lied to.

> > >Maybe that is ok in your book but not in mine.

> > >

> > >What does it prove about the IFU's? Absolutely nothing. It

does not

> > >prove that they are unsafe or safe.

> > >It does not prove they are effective or ineffective.

> > >It does not prove that they are overpriced or underpriced.

> > >It does not prove whether they will last for 100 treatments or

100,000

> > >treatments.

> > >

> > >Does this mean I would not recommend one? Absolutely not.

If I had a

> > >child and the only way I could get treatments was with an IFU I

would not

> > >hesitate to buy one.

> > >

> > >However, I would want to see some type of testing documentation

by an

> > >independant laboratory that the chamber had been tested under

pressure,

> > >the type of testing, and the results of those tests. I would

want to

> see

> > >documentation of testing on the safety and wearability of the

zipper and

> > >any other components which were used, including the small

compressor

> used

> > >to put the air in the chamber that my child would be

breathing. I think

> > >that we can all agree that if a company has a product good

enough for

> > >someone to get into under pressure, the company should be

willing to

> > >provide these test results for an item they are getting 10 to

20 thousand

> > >dollars for, shouldn't they?

> > >

> > >ly, the 510k does not mean that much on these inflatables

to me

> > >except to insure me they have met some safety criteria. Now

what do we

> > >have to show for safety?

> > >

> > >The floor is open for comment? Anyone?

> > >

> > >CAUTION: This is not an OXYHEALTH bashing forum so do not

turn it into

> > >one. Instead, why not work together to find out if the

safety issues

> > >are clear or not. I never meant it to be a bashing forum and

still do

> > >not. It all started with a simple question, Do they have a

510K

> > >clearance or not. They do not according to the FDA. If I

have

> missed

> > >something, help me out here and get me the numbers.

> > >

> > >My opinion:

> > >We have at least 5 types of people on this board right now.

> > >1.) Those who would like to see the inflatable chambers fall

flat on

> their

> > >face. This may be because: (A) they offer fierce competition

for the

> HBOT

> > >dollar which is very limited. or ( It may be because of a

degree of

> > >engineering or professional training which requires the safety

issues to

> > >be strictly by the book with absolutely no exceptions.

> > >

> > >2.) Those who have an interest financially in the success of

the

> > >inflatable chamber whether it be in the form of financial

compensation

> > >directly from Samir Patel or for some other reason.

> > >

> > >3.) Those who are parents or caregivers who own a IFU and have

now

> > >discovered they may have been deceived and need to know if it

is really

> > >safe or not. They have gotten results and like what they have

but they

> > >want something to show them they have not been decieved and

they want to

> > >continue with their chamber with no fears because they have

that right.

> > >

> > >4.) Those who are parents are caregivers who would like to

purchase a

> > >IFU but want to make certain it is safe. They probably don't

care about

> a

> > >510K clearance but they want some type of assurance in the form

of

> written

> > >documentation that certain safety and wear tests have been

performed and

>

> > >they have that right.

> > >

> > >5.) Those who would like to just find a way of providing hbot

to those

> > >who need it, whether it be with an inflatable or hard shell

chamber, or

> > >the combination of both as long as it happens and happens

safely.

> > >

> > >What do we do? We quit all the secreacy and crap. We quit

lurking in

> the

> > >bushes waiting for someone to make a mistake so we can leap on

them. We

> > >all begin looking for compromises with one thing in mind, # 5.)

above.

> > >Is that going to happen, Of course not. As long as money is

involved,

> > >we have no way of knowing who to believe, who to rely on, who

to listen

> > >to.

> > >

> > >I bring these issues to the forefront because they continously

stand in

> > >the way of progress. There are two many sides to the story.

No one is

> > >winning. Everyone is losing.

> > >

> > >If you have any information which is holding up progress or

which is

> > >serving only the mighty dollar and needs to be exposed,

whatever it is,

> > >please email me, notify me. It must be verifiable. This

will be my

> > >last summer of this battle. If the hyperbaric community does

not want

> to

> > >work together to make it affordable and available to everyone,

I do not

> > >want to be involved. I will leave the community and continue

to do what

> > >I can on a private basis. I will probably be hated by the

professionals

> > >but that is not a problem, I have a lot of friends for the

right reasons

> > >who I will not lose. I think its time we straighten up and

fly right as

> > >my Dad used to say. We have a family in Utah who has a child

in need of

> > >hbot. The father is disabled and needs HBOT. The father has

lost his

> job

> > >because of his disability which could be helped with hbot.

They have

> > >lost their car and their home. Yet they have no hope of

getting hbot.

> > >Do you see something wrong with this picture. I do. If you

see

> > >something wrong with this picture are you willing to do

something about

> > >it?

> > >

> > >True colors will show up before it is all done and said.

> > >

> > > Hartsoe

> > >www.miraclemountain.org

> > >

> > >

> > >

> > >

> > >

> > >

> > >