Archive for January 15, 2008

Just a note to let readers know that Pacific Health Options are the only group in the whole of North America with FDA approval for the SCENAR. Don’t let Dr Jerry Tennant or others tell you different. Tennant doesn’t have a SCENAR but clearly sees it as competition for his own knock off device and wrote to me that the Hache’s don’t have FDA approval and they have an “honesty” problem.

Well, who has the honesty problem? I have seen the Hache’s FDA documentation and here is a note from John Hache with their details for anyone to peruse:

Dear Keith,
This is a copy of our registration with the FDA.

We are registered under HCC5050 (Biofeedback), exempt from 510(K) as type II medical device. For full FDA approval, we would have to register as a TENS device, which is something for the future, with proper funding but has its restrictions as you know – TENS devices need to be scripted.

You will notice that 5-Element Therapeutics Inc. is the company name that it is registered under. This company is ours, though we now operate under the name of Pacific Health Options Inc., we have kept 5-Element Therapeutics operational because of our registration with diverse programs.

This is important and so I thought I would blog you the facts as they are coming to me. Basically, others are bringing in the SCENAR under the FDA radar and leaning on the Hache’s note. Write and thank them!