Not all electro-acupuncture devices are created equal.
Join us for an exclusive interview with John Hubacher, founder of Pantheon Research, to learn more about the FDA approval process for electro-acupuncture devices.
Not all devices are FDA approved in the US. Look for the 510(k) rating under BWK (neuromodulation) for peace of mind. Visit https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm and use code BWK.
Remember, devices with product GZL are only meant to be used transcutaneously – or applied to the skin via electrode pads. GZL devices must not be used subcutaneously – or applied to acupuncture needles that penetrate the skin!
Remember, devices with product GZL are only meant to be used transcutaneously – or applied to the skin via electrode pads. GZL devices must not be used subcutaneously – or applied to acupuncture needles that penetrate the skin!
We at Neuropuncture trust Pantheon e-stims for their safety & accuracy!
Dr. Corradino:
Well, hello, everyone. My name is Dr. Michael Corradino. This is John Hubacher from Pantheon Research.
And you know there’s something that’s been coming up in social media, specifically in our profession. And one thing that we try to do with Neuropuncture, is really try to raise the standards in our profession, and really elevate our profession, put it in the heart of mainstream medicine, where it belongs. And I believe in doing that we have to use proper devices. Right? That’s just that’s just quintessential.
So, I brought John on with me today because I want him to explain to us the FDA regulatory processes, and how our devices become approved to the FDA and why that’s important.
So, John, thank you for joining me. And why don’t you just begin by just telling us a little bit of your history and the time that you’ve spent in electrical acupuncture research and dealing with the FDA.
John Hubacher:
Thanks, Michael, and thank you for having this discussion. I’m John Hubacher, the CEO Pantheon Research. We’ve manufactured and designed electric acupuncture devices made here in the United States.
I go back to about 1982 with this when we started to look at machines and decided that the machines on the market needed some upgrading. And so, we started to create a business out of this. And we’ve been through about 10 iterations of equipment. So here we are today with advanced equipment.
And so, my involvement is both with research, we publish papers peer-review journal on electronic puncture, topics, standards, procedures, usefulness, etc., as well as try to give talks on theory, and how it relates to the mechanisms of acupuncture. So happy to be on this discussion today regarding FDA regulations of electro-acupuncture devices, which is a quite important part of the whole thing.
Dr. Corradino:
Absolutely. I mean, acupuncture right now is has been exploding for decades, like I think we could say that. And recently electro-acupunctures really get a lot of notoriety, a lot of traction, a lot of clinical efficacy comes out from it.
And now we’re looking at the FDA. How does the FDA, when and how do they actually regulate? And why do they regulate these types of devices? And how do they do that?
John Hubacher:
Well, the FDA is our federal government entity that attempts to keep the public safe. That’s their goal – safety. And so, there’s a lot of machines and a lot of devices for medical purposes. Everything from a Q-tip from a pipette all the way up to an MRI machine has to be regulated by the FDA in order to demonstrate safety for the public. And it’s quite a process.
There’s perhaps slightly overregulated under some circumstances, but they do the job, and it’s a very important, and the FDA really is our friend overall in the process, in my opinion, after working with us for many years.
The FDA’s job is to create safety amongst the public. So, an electroacupuncture device, like all electronic medical devices, does have to go through rigorous system of testing in order that we comply with the FDA standards of safety and manufacturability, and these are quite extensive.
For instance, when we got our FDA registration many years ago, we went through about 35 different tests.
Dr. Corradino:
Wow!
John Hubacher:
And it’s an expensive process. It took months to do this and so this is all in the purpose of making sure that the devices are a top-notch safety and manufactured according to standards generated by teams of doctors and physicists. People who know the field in the FDA create these things to create safety amongst the public.
So, when you have an electro-acupuncture device it has been tested according to standards for electro-acupuncture. And it’s a very unique category of electromedical equipment. It’s quite different than the similar but different category called TENS, transcutaneous electrical nerve stimulation. And there are 2 very different categories of testing, because they have different ways of applying electricity to the body. The TENS machines have large surface electrodes one inch square, 2 inch square, that go on the surface of the epidermis. The electro-acupuncture machine, of course, has a needle percutaneous, inserted into the skin with a fine needle point that goes into the tissue and because of this they have very different safety standards.
So, an electro-acupuncture device has been tested, if it’s registered with the FDA, according to a whole unique set of safety standards that we do have to comply with.
Dr. Corradino:
Okay? And now there are different, I remember when we looked at it, the FDA for just the broad category, right? There were different categories. And then there’s that 510k. Then there’s the BWK and the GZL.
Can you kind of just explain that for us for any practitioners I might want to investigate to make sure they’re using proper devices, so they don’t hurt their patients, and God forbid they don’t get sued.
John Hubacher:
Well, this is correct. Now, the FDA, it’s actually, if I can remember correctly, called the Center for Devices and Radiological Help (CDRH), publishes public lists of medical devices that have registered through the 510K process.
What is the 510K process? It’s merely the law regulating medical devices, and it’s called, according to the legal terms, the 510 K regulations, so they call them 510K’s.And this is the legal system that was adopted by Congress that applies to the FDA, and it governs the what’s called pre-market approval for medical devices.
If you have this thing called a 510k, you as a company, have taken your medical device and you have registered it according and been through their testing procedures. You have registered it according to what they call a product code. So medical device has a 510K, and it has a product code under which it’s regulated.
The product code for electro-acupuncture devices is a 3-letter code. This is called BWK. BWK is the product code for electro-acupuncture.
Dr. Corradino:
And all electro-acupuncture devices, if they’re approved by the FDA, show the safety of it for electrical acupuncture will be 510k BWK.
John Hubacher:
Exactly. That’s exactly true. And so, we can provide links, perhaps to demonstrate where people can look this up on the FDA website. It’s public knowledge. And yet there’s a list of all devices that have been registered through the FDA 510K process for BWK. Or specifically electro-acupuncture.
Now, it’s illegal to have a device that you make false claims about, or you describe, is a misrepresentation they call it, for its registered applications.
Electro-acupuncture device registered with BWK, and you with your 510K, you are allowed to use it for electro-acupuncture, according to how the States regulate your scope of practice.
You can’t use a TENS device, according to law, as an electro-acupuncture device! And in fact, it may not be safe because they’re quite different. It’s important that distinction is known to people.
So, what we as practitioners can do is go to the relevant FDA 510K product code website and look up, “Hey, is my device listed there?” And this does go back all the way to 1976, when the first devices were beginning to be regulated, electrical devices for acupuncture, and they grandfathered in some of the older devices. And since then, people have been creating new machines.
Dr. Corradino:
Let me just go like this for a second. Pull this up here. And I think this is the FDA list right here. Because it’s not easy finding this particular link or this page on the FDA site.
Go to https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm and use product code BWK.
And what we’re basically seeing is this is up until basically 4/19/2024 results for BWK, there’s only 23 results. And one thing that I saw here that I just want to point out is that there are companies with specific products, right? And we see that like, I know everyone is familiar with the Ito, right? The Ito has one product that’s FDA approved for electrical acupuncture. ES130, not all of them are!
And then P-STEM. I’ve talked about that. That’s the original device that medical doctors use. And then I saw Pantheon.
You know, John, one thing here is your whole company is listed. It’s not just one product. So, I would take away from that, and that every single one of your products that you produce, you follow the FDA guidelines for electrical acupuncture, and they all have BWK product codes. Is that correct?
John Hubacher:
Yeah, this is correct. We have the 4-channel device, the 6-channel device, the 8-channel device, the 12-channel device, and then device called the 9C3I. And those all were registered with the FDA. And it had gone through the appropriate testing procedures. So, all of our product line is along that line. So, you can go to that particular link. And you can say “Hey, do I see my particular device and made by my particular company here.”, and if not, then your device is approved for something other than electric acupuncture, probably approved for TENS.
Dr. Corradino:
Yeah. Find out.
John Hubacher:
If you go through the devices that are commercially available and represented by distributors in this country, look it up to confirm that your device is, in fact, electro-acupuncture approved and not just approved for TENS.
Dr. Corradino:
Yeah, you know, I just want to say how important that is because I’ve been in this field obviously for many, many years. I love doing research. I focus on neuromodulation with electro-acupuncture. That’s what I teach in Neuropuncture. And I have got to say that, yes, if we could use the TENS machine, it would be great! Cause I’ve looked at advanced physical therapy, TENS units that are really big, and you could adjust pulse width, wave form, polarity, and everything.
And you’re not allowed to do that with EA, because the electron delivery into the needles, if the tissues could be much different and it could definitely be dangerous, I think.
So please be careful, everyone. And I just want to point out here that looks like the first device for BWK, or for EA, was it back in 1979, and then 84 was the next kind of year everyone broke through.
Alright, nice, good to know. This is actually a paper that that we actually published back in 2016. Okay.
All right, John. Well, listen, I think that is really, again, important for everyone to know. I want you know, I just think we have to be mindful. Okay, in our profession of just using good equipment and making sure our patients are safe, and we have effective treatments.
John Hubacher:
Also, Michael, there’s it opens up the open question of litigation, which we, of course, live in a kind of a litigious society, and we all have to be careful, and us as practitioners need to know that there are proper procedures under which we can be protected, and then, if we are outside those procedures, then we may be open to liability.
Dr. Corradino:
Absolutely.
John Hubacher:
Using an FDA approved device means that we are on the umbrella of protection. With respect to possible litigation liability issues. And if we’re using devices in our practice that are not FDA approved for specifically electro-acupuncture, we could open the door to something we don’t want.
Dr. Corradino:
Absolutely, absolutely. And I’ve said this before. I’m very familiar with litigation work from family members, and you know, your malpractice is not going to cover that. You’re going to be liable for that. So, your malpractice, like, “I’m not writing that check”. And then it’s going to come out of practitioner.
Now, last thing, I just want to say again, because I know that I use all the Pantheon devices and all the research that we do in Neuropuncture, all the doctorate programs, all the projects are being done, we use the Pantheon.
Let me ask you. I know that you talked to us a little bit. Can you share with me some of the work that you found out? How many papers and were there any papers that were actually published using the Pantheon device outside some of the work I’ve done. What did you come across.
John Hubacher:
Wow! Michael, this is true. Hold on a second. I’ve got a stack of it right here. It’s kind of good for a visual hold on.
Dr. Corradino:
Yeah. Please. Excellent!
John Hubacher:
This, is it? These papers here? There’s over 50 of them. Our device has been used in over 50 published peer review studies demonstrating efficacy and treatment. And they’ve been using research studies. And so, we actually have a good track record that’s published peer-review studies to demonstrate that our equipment works. And it’s widely used in the research community and published in peer-review journals.
And so, it shows, according to the peer-review publication, process, effectiveness and treatment.
There was a very interesting study that was done, actually. Wonderful to find it! There was they, a group of people, a large group of doctors were wondering if the 510K process was valid. If it was rigorous enough! So, they took a if I can describe this briefly, they took a sample year, which was, I think, 2014 to 2015, and there were about 6,000 devices approved in that time period. They randomly sampled. a thousand of those devices to find out if any of those devices had peer-review studies to demonstrate that they were effective. Pantheon was one of only 4% of the devices that had a peer-review published study demonstrating effectiveness!
So, I was very happy to find that that we actually, out of a random sample, made it into the top 4% of the of the published studies to demonstrate that the 510k, given by the government, was actually a valid thing. And then there’s research to show that our devices worked for the intended application electro-acupuncture. So that was kind of, yeah, wonderful to see that.
Dr. Corradino:
Absolutely, congratulations on that! That’s great to know. You know, I’ve used these since I’ve got one. I’ve never stopped. We teach how to use these!
So, I think if anyone’s interested in learning more about the Pantheon, you could check out PantheonResearch.com. And John has all of his instruments online that you can purchase. And you can always check out my work and come to any of my workshops. And I teach this online how to neuromodulate your patient’s nervous system back in health using electro-acupuncture at Neuropuncture.com.
If you have any questions, please feel free to email either one of us. And we look forward to having you guys have great success in your professional career.
Thank you, John. I really appreciate you.
John Hubacher:
Thanks, Michael. Thank you so much for the discussion.
