Cannot determine what type of medical device this product is....

insect warfare

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#1
I'm currently having some trouble with this one....

Personal alert systems (i.e. Life Alert, etc.) - I need to know:

1) what medical device definition this falls under, and
2) what class of medical device this is

I have exhaustively searched U.S. FDA regulations, but no luck so far in determining either of these. Any takers?

Brian :rolleyes:
 
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L

lfrost

#2
I'm currently having some trouble with this one....

Personal alert systems (i.e. Life Alert, etc.) - I need to know:

1) what medical device definition this falls under, and
2) what class of medical device this is

I have exhaustively searched U.S. FDA regulations, but no luck so far in determining either of these. Any takers?

Brian :rolleyes:
Brian,

Try a Class II with the procode: ILQ.

That is the code that the FDA told us we needed for our device. Which is similar to Life Alert's device.

Hope this helps.
 
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