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Lifewave & FDA Registration
"The FDA has almost completed our registration as a type one medical device."
What Does This Mean?

To Lifewave affiliates around the world this will be equated with "FDA Approval". They will consider themselves bullet-proof from any future FDA actions. Lifewave corporate will no doubt spin this "registration" as some sort of acceptance by the FDA of the Lifewave patch as a legitimate "Type One Medical Device".

What is a Type One Medical Device?

Apparently, "Type One Medical Devices" include bandaids, eye patches, skin protectant, adhesive tape, bandages and cast components. Do a little searching of your own - it's interesting stuff:

Product Classification Database

So how will Lifewave advertise their patches once they are classified as "Type One"?

"Try the exciting new Lifewave patches! Our 3M adhesive keeps the patch on tight while our
resonant energy transfer nanotechnology stops 40% or more of the bleeding within just 10 minutes!"

From now on Lifewave will just be a bandage company.

Why Did Lifewave Register Their Patch With the FDA?

MLM companies LOVE to say things like, "The State Attorney General has reviewed our product and approved it", and, "Our product is manufactured in FDA approved laboratories".

Meaningless tripe...

No government agency preapproves any product or company and using an FDA approved laboratory tells you NOTHING about the quality of the product being manufactured. Lifewave is registering the patches because it HAS to:

Who Must List

An owner/operator of an establishment not exempt under 21 CFR 807.65 who is engaged in the manufacture, preparation, propagation, compounding, assembly or processing of a medical device intended for commercial distribution (marketing) is required to list its device on form FDA-2892 within 30 days of entering the device into commercial distribution in the U.S.

Medical Device Listing

Does this mean that the FDA has "APPROVED" the Lifewave patch in some way? Not in the least.

Listing of a medical device is not approval of the establishment or a device by FDA. Unless exempt, premarketing clearance is required before a device can be marketed (placed into commercial distribution) in the U.S. No listing fee is required.

Medical Device Listing

In summary, Lifewave has registered their patch device because they are required to and they are registering it in an inappropriate category, along with bandages and eye patches. Perhaps they are hoping to fool the FDA into thinking they are nothing more than a fancy Band-Aid. Unfortunately, Lifewave will remain accountable for all claims of cancer cures, increases in HGH, serotonin and collagen levels, muscle growth, and all the rest of their silliness.