Hyperhidrosis Forum

Does anyone know why the FDA will not allow Hidrex into the United States?

Is it unsafe or something?

Hey kellbokke, HIDREX is used all over Europe at home and in physician operated clinics too, so it is safe. The company has applied for direct sales in the US per Markus Bindner and should definitely get FDA approval for that by next year. If you are worried, just try a homemade machine this year and then purchase HIDREX next year when Markus has a shop in the US.

There is also another electricity based machine sold in the US called Fischer MD-1a. I have never tried it, but the FDA has approved it so I am guessing they have no problem with electricity based machines and safety.

So the FDA has not approved Hidrex.

So why are they trying to import it?

Have they done human clinical trials on the Hidrex in Europe?

The FDA will accept European data that demonstrates both safety
and efficacy. Many European companies have done this.

The Drionic for one underwent extensive clinical trials in the U.S. at UCLA before it was approved for use in the U.S. and Europe.

Why doesn't Hidrex submit clinical data too?

Opening a shop in the U.S. has nothing to do with getting Pre-Market Approval.

I have never heard that Hidrex or Idromed is being imported into the US. I am definitely not importing the machine if that is what you are implying. This site, the verysweatybetty site, and several others have found the machines to be very good and therefore promote them for our worldwide audience. In fact, the US based International Hyperhidrosis Society sold both Hidrex and Idromed on ebay in the past year and they are asking users to give them feedback. Of course my feedback is positive:-)

You can buy all iontophoresis machines on ebay when available. So even US machines are sold in other countries via ebay by their users. Drionic itself is sold in numerous countries where it does not have local FDA type approval.

HIDREX and Idromed are both owned by very reputable German companies and have been approved for sale in the EU where the safety standards are even higher than in the US. I am sure they have submitted all the data in the EU (since doctors use them at clinics), and now Markus told me that FDA approval is guaranteed. They will open a shop in the US soon and you can call them.

Drionic had some problems in the past in the US with the FDA:

https://web.archive.org/web/20120302142 ... 146585.htm

Drionic is cheap, but when I bought it, the batteries ran out after one month! It become very expensive to replace the proprietary batteries every month and pay for shipping. I am surprised that the US FDA gave them approval to make their own expensive batteries. Some people on this forum converted Drionic to accept regular Duracell/Energizer etc... batteries that you can get very cheaply when on sale at your local pharmacy. These people had successful results and saved 100s of dollars in the long run. With Fisher MD-1, you do not need batteries.

Also, for me, Drionic did not work in the one month I tried it. Both HIDREX and Idromed worked in two weeks.

For safety data, you can e-mail the owners of any machine you are interested in and I am sure they will send you the information.

kellbokke wrote:So the FDA has not approved Hidrex.

So why are they trying to import it?

Have they done human clinical trials on the Hidrex in Europe?

The FDA will accept European data that demonstrates both safety
and efficacy. Many European companies have done this.

The Drionic for one underwent extensive clinical trials in the U.S. at UCLA before it was approved for use in the U.S. and Europe.

Why doesn't Hidrex submit clinical data too?

Opening a shop in the U.S. has nothing to do with getting Pre-Market Approval.

Dear Kellbokke, I assume you are the owner or an employee of Drionic.

This is Markus from iontophoresis-device-dot.com and I want to clarify some things for you. Although, we are presently not FDA approved, we are eagerly working on this approval and will get it soon. The final step is minor, because we already have much worthy approval in Germany by the world renowned local medical board. This approval is quite stringent and of an unquestionably superior quality.

The information you gave, e.g. that Drionic is approved in the EU is completely false. If it is, please show me the approval document. I know that Drionic does not even have the CE mark! Without this, you would not even be allowed to sell a hairdryer in the EU, forget about a medical device.

Redarding HIDREX being denied entry, another lie. No-one denies HIDREX entry. We ship many of them worldwide without ONE denied entry to date (up to now, only Croatia has been a bit difficult, because of their drug agency, but we were approved there too recently)

Regarding your questions:

So why are they trying to import it?

Because people are looking for for professional quality machines when they don't have success with cheaper ones, and they are right to do so. Better to try all options before going under surgery! Also the final consumer must have a guarantee that the devices are really safe, and this we can guarantee with he highest approval on the market: our devices fit German medical law. Regarding FDA approval we have the best proof of security, but it is not our fault taht the FDA is so slow. We filed registration with them over a year ago.

Is it unsafe or something?

Take a look under www.bindner.com, there you find docs for CE- class Iso certs and MPG approvals on the bottom of the iontophoresis pages

Wait a bit and you will see the documents for the needed UL-confomity and FDA approval in the same pages above.

As you might now, the FDA is not the fastest when approving German companies. Maybe they want to protect US companies from competition, but because we have now promises the FDA of starting our own US-based company, it won't be long before we get FDA approval.

Hidrex has undertaken the World's largest studiesfor iontophoresis in German university clinics, and HIDREX machines are installed in more than 500 clinics in Germany. Can you say the same for Drionic?

a clinical trial is laughable against a real study - "trial" - this says it all! Before such a device is approved in Germany you have to make a successful study, and a trial is never enough for a "first" approval. Later you can point to this study, like all German manufacturers have done after entering the market

Almost all manufacturers of ionto devices point to these studies made by Hidrex and prof. dr. hoelzle from University Clinic Wuppertal - the former inventor of the hidrex devices - and surely you must know of this. If you don't, then please give me your mailing address and I will send you the studies in English, included the newest about pulsed current iontophoresis machines.

When claiming unfairness, I would pass the ball to you as YOU sell the Drionic over a European base and your device is not CE or MPG approved and as I see it, your machine would never get approval in Europe because of many non-conformity reasons.

The doctor in Ireland that you sell to does not seem to know that he is one step from loosing his license in Europe since he is not allowed to do this. I would never do something similar with a partner, to let him run into such risks! This is a NO-GO for me and my idea of doing business.

What we do is legal: we sell these units from EU ground and no-one in the US does something illegal when importing a unit. You can buy them legally in the EU, and import them legally into the US. You are not allowed to distribute them directly from US ground at the moment because of lack of final FDA approval. We are not selling riffles or atomic waste, this would really be illegal to import! (although as i know they could be sold to almost everyone in the us, for this i would be anxious!)

even some us-assurances cover the costs or part of the costs and accept our invoices too.

We will open a us-office next year with a brand new us-company and maybe we could work in some kind of way together instead of combating us. I would invite you to sell our professional products in your shops, and maybe we could ad your product as a low cost unit, for this who cant afford it to buy a professional clinic device.

We don't compete with you, because we are far and away in another price dimension with another machine class, we are 7 times more expensive with our best machines, although they are in my eyes highest priceworthy compared to others...

I know you are anxious, but you don't have to worry since there are so many targets out there for you to sell your cheap machine to...I would rather be unhappy about the 2*9V -block (in addition=18V) homemade iontophoresis machines if I was in your shoes. They are in a low current range where you really have your competition. We musn't be afraid of this because many homemade machines do not work. When you look at our astounding success rate and money back guarantee for 8 weeks, and the fact that we drive a high current with smooth pulsation -- this is the main key for a high success rate, a low current device could be very easy sampled together for 10 bucks.

sincerely

Methinks this forum is looks and sounds like a front for Hidrex/Idromed.

No organization has more respect than the FDA for its painstaking approach for product approval.

If your product is FDA approved it is approved if it is FDA approved not it is not.

Welcome back kelbokke (I assume you are Drionic's owner?). This website is not a front for anything and you will see that in my testimonials for Hidrex, I mention its advantages and disadvantages. Same with Drionic.

It is interesting that the International Hyperhidrosis Society in the US has sold Hidrex and Idromed on ebay, but not Drionic. Maybe you should also ask them why they prefer European machines to the cheap Drionic? Another hyperhidrosis site owned by Very Sweaty Betty is also now advertising Hidrex and Idromed and you can see that slowly, everyone is realizing the difference in quality.

There is also another better product than yours being sold in the US called Fischer Md-1a. The owner of that machine was semi-interested in advertising on my site, but did not end up doing so. If he ever contacts me, I would gladly advertise that product too. Then I would be a front for three iontophoresis machines:-) I also advertise various deodorants and antiperspirants for armpit sweating, but you are not so worried about those it seems.

I have allowed you to post on these forums because I dislike banning anyone or any post. However, with your false accusations, you are testing me and I will ban you. So if you have nothing useful to add besides promoting a cheap product and disparaging quality products, please do not post here again.

Also, you never addressed the question of how you are selling your product in so many countries and Europe legally (including to an Irish doctor) as Markus pointed out, and you also did not address that link regarding the very serious FDA complaints against your product.

Wethinks you guys are protesting way too much.

Let's remember that good science and good medicine are based on
good evidence. If the Hidrex has good data it will be approved by
the FDA. But at this point in time it is very simple the Hidrex is not approved by the FDA.

Why do you guys keep talking about the Drionic? Is the Drionic that much better than Hidrex? You keep claiming that Hidrex is better than Drionic but you do not put forth a single piece of hard clinical evidence to support this assertion so I must conclude that in fact the Drionic must work a
whole lot better than Hidrex because it has clearly been the worldwide market leader for iontophoresis machines for over 25 years. Just claiming
the Hidrex is better doesn't make it so.

This isn't a derogatory comment it's simple fact the Hidrex is not approved
by the FDA and that is why the FDA stopped its importation into the
United States....it's not approved for sale in the U.S. The FDA is the most highly regarded medical technology regulatory authority in the world because it does not allow medical technology companies to take short-cuts to gain approval for any product.

By the way we just called Drionic on their toll-free number 1-855-DRIONIC and the confirmed that Drionics are sold legally throughout all of Europe and in over 40 countries around the world and that we believe is the truth. Finally, Kellbokke, LLC is a pure research foundation and it does not own any part of Drionic. Kellbokke, LLC is based in New Jersey while Drionic is based in California.

Kellbokke, LLC
Princeton, NJ

I looked up your IP address and it tracks to the same city in California where Drionic is based.

So you are a liar and are now banned.


I tried Drionic for a month and it did not work. And I could not even put my feet in it comfortably as its too small. Very poor design, as is commonly mentioned all over the internet by users if you do a search. I posted my Drionic testimonial page on the main site years before I tried Hidrex or Idromed, so it is not like I am changing my mind. Many posters on the internet say the same thing as me. And the whole proprietary battery thing with Drionic is a joke. The only advantage of Drionic is the low cost, and you have your own market there.

Your grammar, unprofessional first post, bias and general support of Drionic makes it obvious that you are not who you say you are.

As a "researcher" you could have discussed the positives of Drionic over other machines if there were any. Instead, you resort to juvenile comments and use innuendo and words like "methinks" and "wethinks."

This industry is filled with people like you who have zero interest in solving our problem.

Trololololol