AspieForty
Supporting Member
Joined: 4 Apr 2010
Age: 54
Gender: Female
Posts: 568
Location: North Carolina, USA
21 May 2010, 9:57 pm
AspieForty
Supporting Member
Joined: 4 Apr 2010
Age: 54
Gender: Female
Posts: 568
Location: North Carolina, USA
21 May 2010, 10:16 pm
Strapples
Supporting Member
Joined: 30 Nov 2007
Age: 33
Gender: Male
Posts: 17,861
Location: Chicago Area IL (FAR FROM AUTISM SPEAKS)
21 May 2010, 10:18 pm
AspieForty wrote:
Strapples wrote:
pressure suits DO exist. they are called G-Suits and are worn by fighter pilots not specifically designed for autism one would need an air compressor to fill it nd a good seal over the valve.
The question remains, would your insurance pay for the cost of such a suit? Evidently, because this article claims,
Quote:
http://www.aetna.com/cpb/medical/data/600_699/0696.html
"There are published anecdotal reports (the majority of which are published in the Russian language) of children gaining in speech, fine motor control, as well as movement with suit therapy, but no randomized controlled clinical trials of suit therapy have been published. The U.S. Food and Drug Administration has classified the Adeli Suit and other similar devices as a class 1 limb orthosis (brace). Thus the Adeli Suit is exempt from the premarket notification procedures of the FDA and the manufacturer is not required to provide evidence of efficacy prior to marketing."
"There are published anecdotal reports (the majority of which are published in the Russian language) of children gaining in speech, fine motor control, as well as movement with suit therapy, but no randomized controlled clinical trials of suit therapy have been published. The U.S. Food and Drug Administration has classified the Adeli Suit and other similar devices as a class 1 limb orthosis (brace). Thus the Adeli Suit is exempt from the premarket notification procedures of the FDA and the manufacturer is not required to provide evidence of efficacy prior to marketing."
probably if a doctor orders a trial and sees functional gains. and pre-certifies then
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AspieForty
Supporting Member
Joined: 4 Apr 2010
Age: 54
Gender: Female
Posts: 568
Location: North Carolina, USA
21 May 2010, 10:35 pm
AspieForty
Supporting Member
Joined: 4 Apr 2010
Age: 54
Gender: Female
Posts: 568
Location: North Carolina, USA
21 May 2010, 11:18 pm
Strapples wrote:
AspieForty wrote:
The question remains, would your insurance pay for the cost of such a suit? Evidently, because this article claims,
probably if a doctor orders a trial and sees functional gains. and pre-certifies then
Quote:
http://www.aetna.com/cpb/medical/data/600_699/0696.html
"There are published anecdotal reports (the majority of which are published in the Russian language) of children gaining in speech, fine motor control, as well as movement with suit therapy, but no randomized controlled clinical trials of suit therapy have been published. The U.S. Food and Drug Administration has classified the Adeli Suit and other similar devices as a class 1 limb orthosis (brace). Thus the Adeli Suit is exempt from the premarket notification procedures of the FDA and the manufacturer is not required to provide evidence of efficacy prior to marketing."
"There are published anecdotal reports (the majority of which are published in the Russian language) of children gaining in speech, fine motor control, as well as movement with suit therapy, but no randomized controlled clinical trials of suit therapy have been published. The U.S. Food and Drug Administration has classified the Adeli Suit and other similar devices as a class 1 limb orthosis (brace). Thus the Adeli Suit is exempt from the premarket notification procedures of the FDA and the manufacturer is not required to provide evidence of efficacy prior to marketing."
probably if a doctor orders a trial and sees functional gains. and pre-certifies then
The one thing I don't know, though is how a doctor would go about "importing" an item like this, overseas from Eurasia and charge it to insurance? The information is there, how to directly order it from them... but how would you charge that to Insurance?
I tried to locate the information... about how "medical things" could be imported... apparently as a big concern would be if it is FDA approved of course. (And a brace would be automatically).
I don't know. Even the Atlanta site was discussing counterfeits, circulating to rip off their pressure suits (in their news items), and the FDA is discussing counterfeit meds and such... but I don't know how it would be imported, and insurance cover the cost??
I hope your doctor can pull that one off. Getting insurance to pay for / order this thing all the way from Russia.
It doesn't appear to be available at all in the United States.
On counterfeits and imported drugs (though sort of unrelated) -- how does one import medical "things". Maybe my brain is short-circuiting. Long day :
----
Imported Drugs
Statement of
John M. Taylor
Associate Commissioner for Regulatory Affairs
U.S. Food and Drug Administration
http://www.fda.gov/NewsEvents/Testimony/ucm113825.htm
Strapples
Supporting Member
Joined: 30 Nov 2007
Age: 33
Gender: Male
Posts: 17,861
Location: Chicago Area IL (FAR FROM AUTISM SPEAKS)
21 May 2010, 11:19 pm
well import products require an IDE IMport Device Exemption DME Durable Medical Equipment.
_________________
check out my website at {redacted by admin - domain taken over and points to a porn site}
When in doubt, ask an autistic. Chances are, they're obsessed with what you need to know.
Autism Speaks will NEVER speak for me
CLASSIC AUTISM
