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

insect warfare

QA=Question Authority
Trusted Information Resource
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:
 
L

lfrost

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.
 

insect warfare

QA=Question Authority
Trusted Information Resource
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.

This answers both of my questions. Thanks a bunch :agree1:

Brian :rolleyes:
 
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