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H8ster

07/10/13 9:17 PM

#42826 RE: Stock_Barber #42824

Regardless of what anybody thinks of the FDA significance, the MPDD is approved. And it is good.

There are numerous trans-cutaneous electroneural stimulation (TENS) portable devices available in the marketplace. However, the leads (i.e., the electrodes) of these devices are designed for static and therapeutic purposes, rather than dynamic diagnosis purposes.

As a result, all those TENS devices are not appropriate for locating myofascial trigger points. The MPDD is.

Until now, there is no current device that effectively locates a myofascial trigger point. As a result, this has contributed to ignoring muscles as a major cause of most common pain problems and, unfortunately, has led to unnecessary testing, injections and medications, and surgeries.

Accordingly, there is a need for a device that can accurately diagnose and locate trigger points, which is portable and ergonomically designed....which is EPGL's, FDA approved and patented, MPDD.

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Squeejo

07/10/13 9:20 PM

#42827 RE: Stock_Barber #42824

Google glass doesn't have to be FDA approved.The medical device it is integrated into will be . All in good time stock barber. Giant trees don't grow overnight.
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CommonVestor

07/10/13 9:27 PM

#42828 RE: Stock_Barber #42824

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

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 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 of their caliber to create their version built 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?start_search=1&Panel=&ProductCode=&KNumber=K&Model=&Applicant=&DeviceName=&Type=&ThirdPartyReviewed=off&ClinicalTrials=off&ExpeditedReview=&Decision=SE&DecisionDateFrom=&DecisionDateTo=&IVDProducts=off&CombinationProducts=off&PAGENUM=10&SortColumn=DecisionDateDESC
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traderfromheaven

07/11/13 12:29 AM

#42834 RE: Stock_Barber #42824

Dont confuse people... google glass doesnot require FDA approval..