Replies to post #42829 on EP Global Communications Inc fka EPGL

[CommonVestor]

Acutally I dont think my post is confusing by any means, on the contrary it shows that the 510k substantial equivalence in the industry is widly used and accepted by other Medical device manufactures. People who are on the board often would agree. The opinion as stated in previous posts is that 510k substantial equivalence is a loose fitting FDA approval and that it holds less importance because it was built with a TENS device as its predicate.

Its clear by my example that this is not the case as other fourtune 100+ companies use this same method of getting their device FDA approved using the 510k substantial equivalence.

QUOTE: It does not say anything about the Google Glass being FDA approved... which it is not.

He never once questioned in his post if Google glass was FDA approved and I think thats pretty B&W, he's stating that the MPDD is FDA approved and that in its self is factual.

QUOTE: Yes, the MPDD is approved by way of substantial equivalence to a TENS device. *** Not once in Jamming1's post did he state anything about the 510k substantial equivalence.

Just to let people know on the board for them selves, as stated in my previous posts. Here is a link of devices from just this year that were approved with 510k substantial equivalence. You might NOT find it surprising what companies are in the list. Anyway for a company to limit engineering fees,manufacturing costs and FDA trails and testing sounds like a great way of cutting costs and breaking even faster on their new product. I cannot in my wonder see how this is bad. I cannot understand why companies such as SAMSUNG( IN THE LISIT, USE LINK BELOW) can do this and it not be question but with EPGL its their downfall. I hope every device they create is approved under substantial equivalence so EPGL can get these devices approved and manufactured. And another note just because they were approved under substantial equivalence doesn't mean that just anyone can recreate a product. If GE spent a 500 million to manufacture a product and get it approved it still will take another company of their caliber to create their version built of the device on their platform. It in no way limits the authenticity of the device their trying to produce in vision of its function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?

Under Decision: Select SUBST EQUIV (SE) and hit SEARCH....The rest will speak for it self.