Use/ danger and abuse of TGA – FDA – 93/42 certification


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TGA approvedthis is in response to Joan’s comment

Dear Joan

what kind of difference, of a massive kind, does the TGA approval make for your work

Kiran Schmidt

Director Inergetix Inc


Hello Kiran,

TGA regulations as I understand them require that any device that has contact with a client requires registration, which is why the CoRe software system did not require the same to be used on clients.

The theory behind CoRe, to the best of my ability I understand, but the rules and regulations here require this registration. I am also bound to fully abide with these rules to maintain my professional membership.

There are advertising guidelines to follow, that I am sure Katherine will be able to fully make us aware of, and inline with these it will now be possible to more openly advertise and promote our work with CoRe.

This is a massive opportunity for growth for the CoRe community.

Many thanks for all you do Kiran. At times I struggle with the science behind it all but I have learnt to let that go and place my focus on what CoRe is doing for my clients, even though I may not always be able to fully explain it, I let the results speak for themselves.




Dear Joan

if I would follow the others I would not challenge your position but confirm it and tell you “Now that we have TGA approval things are much saver for all of you” however I feel it to be my mission to give you “The whole truth and nothing but the truth” no matter how much polarities this creates (as you know DLE is only possible because of polarities).

In other words I am not afraid of the sweet-and-sour taste.

Fact is that these certifying agencies are not established to take some part of the responsibility that is always huge when dealing with sick people from your shoulders and vouch for the safety of a tool that you will be using, once they have tested it.

What happens is – that when a device is declared a medically certified device that the responsibilities of the user become much larger.

Just a few days ago Katherine e-mailed me, saying that she was very worried because a person that had been treated went on a TV show and talked about all the miracles that happened with CoRe and that she was not cautious and the kind of claims she was making for the effectiveness of CoRe and that this could possibly endanger the TGA status for CoRe.

I had to calm her down because this is of no worry to me, any client can talk about any miracles that CoRe has done to them it is not an official position of Inergetix and not even of a practitioner.

Serious problems mostly then occur when you treat a client with whatever modality or tool and then the person gets more sick or even dies. Then there are the relatives who want to find the guilty one or even want to make some money on you.

If you had taken the position that I had always regarded as the most honest and accurate one – that you are doing informational therapy assisted by energetic communicators that are intensity wise so low that you agree with established science that they cannot have any physiological effects – you are also most save – particularly if you had the client sign the “informed consent” that I have posted in our legal section

But imagine you had not expressed it this way but told the client you are using a medically certified device – then you have major new restraining factors

1. does your professional membership allow you to use TENS, magnetic and light therapy

2. does your client have one of the 3 areas of issues for which CoRe has proven effectiveness

a) wounds

b) pains

c) depression

if you do not have 1 or your client has not one of point 2 and you still use the device as a medical tool you are misrepresenting qualifications which will get you in big trouble if you are investigated in the case that your client got worse after the treatment.

Certifications are not there to protect you but to protect the client and give him many more levers to blame and sue you if his fate is to get worse.

Certification agencies are well aware of the responsibility that any certification involves, for that reason, we have the paradox fact that they do not even call themselves as such but “notified bodies” which means nothing and certainly not that they are responsible for any certificate they issue. Even more, they do not even issue “statements of conformity to the law” – they leave this to the manufacturer.

After they have have driven him crazy to find more and more absurd little issues that have to be corrected, to justify the enormous money that such a process is costing, they leave it to the manufacturer to issue and sign a document that “the device now conforms to all the rules that are written somewhere” if he knows them or not, in the end it is his responsibility.

And the same applies to you, the therapist, if you use a medical device, the load of responsibility is on you, if you know all the laws or not you are now to blame if anything goes wrong.

This is the old learning game of evolution, the less we have grown up we want to have authorities that bless our work and that give us the protection that once our parents gave us but existence is not made or designed that way.

A hundred years ago for most people the church had this function, the church authorities were considered to be the “good shepherds” , Nobody ever asked and recognized the fact that there is “NO good shepherd for any flock of sheep” because in the end every shepherd slaughters all his sheep for meat and money and certainly the exotheric part of the church always lived up to this function.

Today many people have replaced this blind faith in religious authority with blind faith in governmental agencies, who in the end also only want their meat – there is no conspiracy behind this – its just the age old way of evolution to teach souls to grow-up.

I am giving you, with the many pages I am writing here on the forum, a new change to redefine your position as a healer, that is uniquely new and so save that we never had one organization challenge this position – but it needs you – to get out of our culturally and individual stagnant believe in authority that so many money makers abuse

let me know your thoughts on that

I will post this exchange on the forum as I know many are in the same position as you

lets help each other



Yes Kiran,

I agree with all that you say. I feel a little that I am dancing to two masters, the truth that CoRe is, and the needs of a regulator. It is a bit of a juggling act.

All my clients sign an informed consent and I insist on privacy for both myself and my client. I talk of “a trouble shared is a trouble halved”, which all agree is true, and follow this up with the statement “and so is an informational healing/balancing”. Not everyone initially gets it, but at least they have something to think about. DLE.

I advise my clients that I am not responsible for their health or any changes thereto. I will use CoRe to find resonances for them, and via communication will make these resonances available to them for their use in creating change, a change that they are fully responsible for. Before they use any attachments to the Health Navigator they need to know that the TGA have approved the device.

Your are right that there is no protection for the practitioner in regulation and heaps for the client, and that is as it should be. I believe in CoRe. If a practitioner does not trust a device then they should not use it, and they should be responsible for the choices that they make in how they use their chosen device.

Again I say that being able to now advertise that the Health Navigator has TGA approval will be of benefit to all users that come under its control.

Best wishes,



Thank you Joan

for risking to open your mouth

This is new territory and we have to support each other in defining a new position and charting this unknown landscape of the informational matrix – that is why I have called it the Health Navigator.

And that you are feeling like dancing “to two masters” this is what I call DLE and there is no way to take this of anybodies shoulders – this is the way to health and evolution – however uncomfortable at times.

Still there are a few contradictions in your reply that are very common and that I want to point out : You say “a trouble shared is a trouble halved” and already in the next sentence “I advise my clients that I am not responsible for their health or any changes thereto” . The first comes from the new age corner and the second of your reading some nonsense legal advice that is so common.

Please read and re-read what I am writing in the legal section

The only step you have to make is to be open and forward about the fact that you are treating/ healing/ curing (not only balancing) on the spiritual and informational level and that all physical or energetic changes that go along with it can only be understood as coincidental and that you agree with established science that your work or the minimal energies applied by the Health Navigator equipment can not have any physiological effect – this is a wonderful catchy all – that turns what has hold against subtle healing methods since hundreds of years in our favor – and you are as safe as you can be

AND YES for your business and our business it is of great value that now have the delicious bait “TGA and 93/42/EEC approved” for the majority of people who is and always will depend on authority approval


About Author

Inergetix Founder Born on 1962 in Stuttgart/Germany, Founding of the Instrument Systems Corp Munich.

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