RE: FDA requirements for beauty treatment device

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 specifi

Re: FDA requirements for beauty treatment device

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 cla

RE: FDA requirements for beauty treatment device

Nick - this sounds like one of those electric skin/muscle toner devices. While I didn't find specific reference to this type of device, it appears to be treated as a medical device and not a cosmetic. Refer to http://www.cfsan.fda.gov/~dms/cos-derm.html for another type of product that was mi

RE: FDA requirements

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 f

RE: FDA 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 goo

RE: FDA requirements

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 AM

RE: FDA requirements

Martin, Check out 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 h

RE: FDA requirements

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 r

RE: FDA requirements

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 compli

RE: FDA Requirements

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 Engineer

Re: FDA Requirements

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 fi

RE: FDA Requirements

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 Dev

RE: FDA requirements

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 d