FDA approval for SCENAR

Posted by on 01/15/08 in SCENAR

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!

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4 Comment(s)

  1. Jerry Tennant | Apr 15, 2008 | Reply

    Dr. Scott-Mumby
    As I discussed in my communication with you, you don’t understand FDA laws and regulations. The only devices or drugs that can say they are “FDA Approved” are devices or drugs that have been evaluated by the FDA using a procedure called a PreMarket Approval. This involves several years of testing under a study approved by an Investigational Review Board. If the FDA approves the outcomes of the studies, it issues an IDE (Investigational Device Exemption) that allows the manufacturer/importer to call the device “FDA Approved”. Devices or drugs that do not have an IDE cannot legally say that!
    The devices that are FDA 510k exempted as biofeedback device cannot say that they treat pain. They can only say that they are used for “muscle relaxation and re-education”. This is the status of the devices that Dr. Hache has listed and he cannot legally say that they are good for anything except muscle relaxation or re-education. His listing of the devices on his website as “FDA Approved” is illegal since he does not possess an IDE for it.
    Devices that have undergone the 510K process to prove that they are “substantially equivalent” to a predicate device are given the right by the FDA to say that they are “FDA Listed”(NOT FDA Approved) for chronic intractable pain and postoperative pain. As far as I know, the only SCENAR-type devices that can legally say they are FDA Listed for pain are my Tennant Biomodulator, the Avazzia devices, and the InterX-5002.

    As I told you in the past, one cannot expect a European to know US FDA law. However, those who break it will eventually be visited by the FDA.

    I would hope that you would know the facts before making a personal attack as you have done on this blog. I have been a long-time admirer of your work and expect more great things from you in the future.

    Be Well!

    Jerry Tennant, MD

  2. Bart Ellis | Jun 3, 2008 | Reply

    Hi,
    I’m giving you another update on my use of the SCENAR for alleviating the discomfort of my Morton’s Neuroma (in both feet.) Having almost relented to surgery to remove the painful little “XX&(##’s), I checked out my use of the SCENAR with the Prof. Basically, what I learned was that I was not using the device nearly enough as I should. Trying to ease the discomfort or pain of a chronic condition is not the same as “treating oneself for a sprained or twisted ankle.” The latter is a “piece of cake” with the SCENAR. However, to remedy a long term problems e.g. 10+years, you have to be more consistent and more aggressive…at least, that is my point of view. To make a long story short, I have now “become friends” with the intimidating device i.e. SCENAR. I know that it is safe to use (providing you don’t take a bath with it!) and that, it will work, but ‘it does so at it’s own time frame…not mine or yours!) I am now using the SCENAR every other day or so, and have gotten comfortable enough with it to try out some new settings. (There are really only a couple settings you need to learn, and, you can learn those quickly, if you get the right teacher!) By using the few settings, and now pinpointing where the problem is, I am getting much better results. However, I have a tendency to “over do” a good thing. If I spend too much time with the puppy, it “bites me in the ___! What that means to those of you who are using the SCENAR for whatever purpose, don’t overdo it! You will experience a state of malaise, which is not conducive to getting work done. Suggest that you keep the time down to about a 1/2 hour. That way, you probably will avoid the “over use” syndrome! If you experience the overuse syndrome, you will have to double your intake of Red Bull! So much for that. Will get back to you with further insights into how to use the SCENAR without being intimidated by it. It really works well!

    Bart

  3. Irina | Jul 21, 2008 | Reply

    Could you please explain what exactly this phrase means:
    Pacific Health Options are the only group in the whole of North America with FDA approval for the SCENAR.

    Thanks,

  4. Alice Pitt | Oct 26, 2008 | Reply

    Dear Bart, I love hearing such wonderful Scenar Stories. You certainly have a wonderful way with words, and you make us all see Susan as a healing super woman.
    all the best
    ALICE

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