Hello Peter,
This may be similar to the product in question:
http://www.alliedhealth.net/micro_ablation.htm
Best regards,
Ron Wellman
At 10:12 AM 4/9/2003 -0700, Peter L. Tarver wrote:
Nick -
this sounds like one of those electric skin/muscle toner
devices.
While I didn't find specific
Hello Nick,
I'd be curious as to what claims the manufacturer makes for this beauty
treatment product. That may determine one thing in regards to potential
misbranding under FDA regulations but if there are similar devices already
on the market in the USA, I would check to see how they are
Nick,
The best site for all this information is the FDA site itself: www.fda.gov.
Click on the medical device section on the home page.
Then choose Premarket issues.
And, then approval clearance. That will take you through the
classification process provide you with the various requirements
Hello Nick..
Try here as a starting point: http://www.fda.gov/
Good Luck ,
George
-Original Message-
From: Nick Williams [mailto:nick.willi...@conformance.co.uk]
Sent: Tuesday, July 04, 2000 11:15 AM
To: emc-p...@majordomo.ieee.org
Subject: FDA requirements
Can somebody give me a
Nick,
Check this out http://www.fda.gov/cdrh/devadvice/16.html#page_index it will
assist in classifying your medical device/equipment for the US market.
Regards,
Mark
-Original Message-
From: Nick Williams [mailto:nick.willi...@conformance.co.uk]
Sent: Tuesday, July 04, 2000 11:15
Martin,
Check out http://www.fda.gov/cdrh/devadvice/dd_asist.html
http://www.fda.gov/cdrh/devadvice/dd_asist.html
I am not aware of any emission requirements. On occasion when the 510K is
submitted and reviewed the FDA will sometimes request emissions testing. If
it never finds its way into
As far as I am aware, the FDA requirements (21CFR) relate to the emission
of X-rays from CRTs within monitors. We always state that any LCD displays
within our products are therefore exempt from the FDA requirements.
I also have on file a letter to all manufacturers and importers of
television
Martin, I have to say that I don't even know what you mean by FDA emission
guidelines. Please elaborate.
My company has installed electronic business equipment in hundreds of
hospitals and medical facilities and we have never been asked to comply with
FDA emission guidelines. Our equipment
In a past life I was with a company that made deep fryers. Though the
tanks were SS, we made the lids of aluminum, but they had to be 1100
series (unalloyed) aluminum to meet the requirements. Unfortunately, I
don't remember what requirements.
Jack M. Burns, PE, CSP
Product Safety
Mike,
I also found the subject of sanitary to be somewhat elusive. Try
the 3A standards from the International Association of Milk, Food,
and Environmental Sanitarians or the Food, Drug, Beverage
Equipment Sanitary Standard #ASMI/ASME F2.1-1982. The standards
will also require/specify
Mike,
I posed this question to the group a few weeks back. See the archive
postings for July 28 and 29 for responses. I also did research and
could not come up with any written requirements for stainless steel. It
seems to just be a commonly accepted practice.
Darrell Locke
Advanced Input
Dear Rebeca Chan,
Based on the information that you provided, a device such as your electrode
device could be classified as a Class I device. A submittal to FDA under a 510k
plan may or may not be necessary. It is hard to say with the limited
information provided. The key question here is how
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