FDA approved??

General Discussion on any topic relating to CPAP and/or Sleep Apnea.
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LSAT
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FDA approved??

Post by LSAT » Wed Oct 18, 2017 8:04 am

Never saw this before.... http://zzomaosa.com/ What crap!!!
Seems like a $10 fanny pack with a tennis ball would work just as well.

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49er
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Re: FDA approved??

Post by 49er » Wed Oct 18, 2017 8:10 am

LSAT wrote:Never saw this before.... http://zzomaosa.com/ What crap!!!
Seems like a $10 fanny pack with a tennis ball would work just as well.
I think it has been around. What irks me is it is by prescription only. Yeah, really dangerous if the patient obtains it on his/her own.

Agree that the $10 fanny pack with the tennis ball would work just as well.

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Pugsy
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Re: FDA approved??

Post by Pugsy » Wed Oct 18, 2017 8:21 am

Holy crap. $190 bucks. I have seen that product before. Maybe with FDA sticker it would be covered by insurance if a doctored Rx'd it??

I don't like the idea of tennis balls though...they would hurt and pain disrupts sleep. Just what I want...more pain to mess with my sleep.
I would think something with foam would be a better choice. Something a little more comfy.

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AdamBaheir
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Re: FDA approved??

Post by AdamBaheir » Wed Oct 18, 2017 8:26 am

I've read that Zyppah is FDA approved, is it right?

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PST
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Re: FDA approved??

Post by PST » Wed Oct 18, 2017 8:56 am

I clicked through to look at the paperwork. The interesting thing about the FDA approval is that the company got it by representing that its product is substantially equivalent to an existing product. In other words, they promise that they are nothing but copycats. This is a normal process. If I wanted to start a company to make aspirin I wouldn't have to prove that aspirin is safe and effective, just that it mine is the same as everyone else's aspirin. It's not much to brag about though.

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Gryphon
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Re: FDA approved??

Post by Gryphon » Wed Oct 18, 2017 10:30 am

Wouldn't be much help for me. Difference between my apnea when on my side VS back was 2 of pressure. In other words when I was titrated on my side it took 11 to keep my airway open but when I slept on my back it took at least 13 or 14 to do the same thing.

It said treatment for positional apnea so if yours isn't positional it's no way an alternative to PAP therapy. 200 bucks does seem insane for a more comphy weight belt with a color matching block of foam attached to the back. Also wearing something around your waist for hours on end could have other undesirable effects.

I like the idea of a back pack with a block of hard foam stuffed in it better.

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palerider
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Re: FDA approved??

Post by palerider » Wed Oct 18, 2017 4:06 pm

LSAT wrote:Never saw this before.... http://zzomaosa.com/ What crap!!!
Seems like a $10 fanny pack with a tennis ball would work just as well.
FDA "cleared" not "approved".

Even "FDA Approved" means "it doens't do more harm than it does good"... doesn't mean it *works*

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LSAT
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Re: FDA approved??

Post by LSAT » Wed Oct 18, 2017 5:25 pm

Here's someone that didn't like it...
https://grandrapids.craigslist.org/hab/ ... 07264.html

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Re: FDA approved??

Post by chunkyfrog » Wed Oct 18, 2017 7:04 pm

Sometimes FDA rubber stamps appear to be for sale.
Cross the right palms with enough silver . . .
Look at some of the silly s*** they have allowed through, and say I'm wrong!

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Re: FDA approved??

Post by Cpapian » Wed Oct 18, 2017 9:26 pm

Too funny! I can't believe someone bought one.

Me and my trusty sewing machine could whip up one of those, nicer too, in less than an hour.

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Pugsy
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Re: FDA approved??

Post by Pugsy » Wed Oct 18, 2017 9:39 pm

I have a friend who tried the back pack thing with tennis balls in it...18 of the little suckers.
She woke up the next morning flat on her back and from the looks of the pressure was there most of the night. (needs a lot more on her back).
She slept all night laying on those tennis balls. Woke up the next morning with major back pain.
We decided that she must REALLY want to sleep on her back and not to fight it anymore and just let the machine sort it out.
Figured if she could sleep through those hard lumps she could sleep through anything and we gave up trying to force side sleeping.

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Gryphon
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Re: FDA approved??

Post by Gryphon » Wed Oct 18, 2017 10:10 pm

WOW - I was thinking big triangle shaped chunk of hard foam but 18 tennis balls sounds very lumpy indeed.

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Pugsy
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Re: FDA approved??

Post by Pugsy » Wed Oct 18, 2017 10:22 pm

Gryphon wrote:WOW - I was thinking big triangle shaped chunk of hard foam but 18 tennis balls sounds very lumpy indeed.
Long ago I did some experimenting to see if supine sleeping affected my pressure needs.
I already knew that in REM sleep my OSA was worse and needed significantly more pressure. So the experiment was to see if I needed the same pressure when totally on my side. It took many nights trying all sorts of things to come up with something that wouldn't let me roll over on my back and was still comfortable to lay on. I wasn't about to use something that caused pain like the tennis ball trick.
To me that is just plain stupid....here I am with sleep issues and I am going to use something that causes pain so it will back me up so that I can get back over on my side....no thank you.

I didn't want to tie something to my body like a wedge. I like to sleep naked. Didn't want to wear anything.

I tried wedges that laid in the bed for be to roll back on to....they would slide out from under me.
I tried bed pillows stacked up...they would slide out from under me.
Eventually I decided to move my head pillow (a buckwheat hull pillow) to my back and use it for support to keep me off my back.
It worked really well because it is heavy enough that it didn't slide out from under me.
It worked sort of like a wedge...I would lean back on it but it kept me sort of half on my side and half on my back. It was comfortable against my back so no pain and it didn't cause me to wake up.

Did that for about a month. Come to find out that even when I stayed on my side for sure all night that I still saw the same rather high pressures in REM...so not supine sleeping related pressures.
Finally abandoned all efforts to stay off my back because I needed the higher pressures for REM and I couldn't control REM.
So now I sleep in whatever position I want and let the machine sort it.

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TASmart
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Re: FDA approved??

Post by TASmart » Wed Oct 18, 2017 10:24 pm

At petsmart they have giant tennis balls for bigger doges- mayt=be that would work. Or me, I go with how my body wants to sleep at night and adjust my CPAP to fit.
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Gryphon
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Re: FDA approved??

Post by Gryphon » Thu Oct 19, 2017 8:25 am

I have the same problem. My sleep apnea doesn't get really scary until I go into REM. Then if I don't have my machine the De-sats were in the 50s. Doctor told me if I hadn't been officially diagnosed and treated I wouldn't have been around in 10 years. I like sleeping on my side but have back issues and sometimes the only comfortable position for me is my back. I have an auto machine now that seems to handle my nightly fluctuations rather well.

On a side note. I also found that as far as air in my gut from the machine. If I'm on my back I'm fine. If I'm on my left side I'm usually ok... but if I'm on my right side I will some times have problems very quickly. I wonder if anyone else has seen this same trend.