Is Healy World’s device FDA approved?
I was going through my daily news research today when I came across this headline from BusinessForHome:
Having previous knowledge of the nonsense claims Healy World makes about its little device, I was surprised to see the FDA was on board.
Not surprisingly, when I looked into it I found out they weren’t.
The give-away that BusinessForHome is misrepresenting Healy World’s presence in the US is that the FDA isn’t mentioned anywhere in their article.
The FDA is only mentioned in the headline, which unfortunately is enough to mislead people.
So, FDA clearance hey.
As I write this Healy World has two two establishments registered with the FDA; Healy GMBH and Healy World USA.
Healy World USA has no products registered with the USA.
Healy GMBH has registered an over the counter nerve stimulator and transcutaneous (over the skin) stimulator for arthritis.
Both registrations are made under the 882.5890 FDA regulation number, which pertains to
a transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient’s skin to treat pain.
Both device registrations are also class 2. Truth in Advertising has more on what that means;
Before a Class II product can be sold it must show the FDA that it is “substantially equivalent” to another product that the FDA has already given clearance.
The reasoning goes that if it’s pretty similar to another “cleared” product then it’s as safe and effective as the other device.
Imagine the review process for Class II devices as a giant game of dominoes where every new product needs to match up to one that is already on the table.
It’s not that hard to do.
Because it’s not that rigorous a review standard, when you see something marketed as “FDA cleared,” it’s sort of like someone saying, “I’m good at dominoes” — it’s just not that impressive.
So in a nutshell, Healy World pointed to an existing device for arthritis, told the FDA “ours is practically the same”, and bing-badda-boom class 2 registration.
As we uncovered in our Healy World review, Healy World markets their device as
a medical device for the treatment of chronic pain, fibromyalgia, skeletal pain and migraine as well as for the adjuvant therapy of mental illness such as depression, anxiety and associated sleep disorders.
The company also claims its device can affect “fitness, beauty, skin care, bioenergetic balance, sleep, mental balance, learning aid, job performance, meridians and chakras”, but that these
applications of Healy are not recognized by conventional medicine due to lack of evidence in the sense of conventional medicine.
To be clear, Healy World have registered their device with the FDA by pointing to an existing product and claiming their device is practically the same.
If you want examples of such devices, just run a web search for “arthritis wearable”.
The first example I came across was BioWavePro (no affiliation), which is readily available from Walmart and comes in at $299.99. On Amazon there’s “nerve stimulators” for “muscle pain therapy” going for $40.
These devices look pretty similar to Healy World’s device, which starts at $470 plus tax.
Healy Holistic Health, which is the same device but comes with “120 different frequency programs from 16 categories for all areas of life”, will set you back $1413 plus tax.
If arthritis was the only medical claim Healy World made about their device, I wouldn’t even be putting this article together.
But it’s not, and that trickles down to how their affiliates market Healy World’s products (click to enlarge the below example):
The take-away here is that the FDA has not approved Healy World’s device for any of the unsupported claims the company makes about its device.
All of that said, I think it’s actually a positive that Healy World are targeting the US.
Considering all the woo science nonsense claims made about Healy World’s device on their website, FDA warning letters hopefully aren’t too far behind.
Update 2nd December 2023 – BusinessForHome has deleted its misleading Healy World “FDA approved” article.
Might want to actually go to (Ozedit: snip, see below)
Yeah we actually provided links to the FDA in our article… which you obviously didn’t read because you didn’t address anything raised in it.
Might want to crank up your “cranial stimulation” settings, your Healy device appears to be broken.
Here is the K# for the device and here is the link to the FDA 510(k) clearance. Took 15 seconds to find.
K191075
accessdata.fda.gov/cdrh_docs/pdf19/K191075.pdf
Cool. How does that address the points raised in the article?
Is your point that is not cleared or that it is not substantially equivalent? (Ozedit: snip, see below.)
No. Next time read the article instead of rushing to post irrelevant spam.
You might very well be doing a service to some people with your site.
Personally, I did significant due diligence about this technology and my motivation had nothing to do with any business opportunity. Be well my friend.
If you’ve got arthritis and bought a Healy device, you overpaid massively.
If you’re going to claim Healy can do anything else, you’re making unsubstantiated medical claims. This is illegal.
How many times do you get these passive/aggressive signoffs from slimebags?
The aggressive ones are far more common bust most of them wind up in the spam bin.
I try to leave the comments that have a dig if they add to the discussion or address the content being commented on.
I myself am guilty of going off now and then but I try to keep things civil.
I bought one of these, it has massive technical issues and I have emailed the company 10-15 times with no response. Looks like I am out $1500.
Hi there,
So….I am a single mom and have been a massage therapist for many years. Not very business savvy at all.
I had CFS from covid for the past 4 months. I tried every western med and alternative therapy, nothing seemed to work. So a friend of mine dropped off his Healy for me to use.
I have to say the day after using it was the first day I was able to be up and active for 12 hours. I don’t believe its a placebo affect because I tried so many other ways of healing that did not work.
So in saying this, I was going to be open minded and find out what I could about the device. There is limited info out there, although I did participate in a webinar last night, the concept is very appealing for energy medicine.
My due diligence is important before I spend the money to become a distributor. your time in writing this article is much appreciated.
After reading this, I have a bad taste in my mouth. Should I steer clear of this type of marketing?
Coming up with the 5K would be difficult for me but I see a market and I do have some marketing skills that could potentially bring in some money.
I am a big believer in karma tho and don’t want to work for a corrupt company. Any ideas?
Healy’s device is FDA approved for specific pain management. Healy has not sought approval for Healy as a device to treat, manage or cure fatigue.
That process would require them to submit peer-reviewed studies confirming Healy has any effect on fatigue.
If you’re not keen on the business but believe the product does something for you then by all means purchase one as a retail customer.
Sounds like you were pitched on Healy with illegal medical claims. In turn that’s what you’d be doing to rope others into the business.
Thank you for this. Someone told me last night that the Healy is an FDA approved medical device for pain relief and it sounded fishy to me. Your explanation makes complete sense.
This is sleight of hand, especially as the device is marketed as being unique and the lady I spoke with told me there is nothing else like it available. I literally know a dozen people who have recommended this to me and rave about it. It seems to have a life of its own.
The website says that the device isn’t scientifically backed by standard medical standards so how can it be registered?
I hope someone can challenge the registration which in my opinion is blatantly misleading. People need to be saved from this BS.
I believe the issue isn’t the arthritic pain relief (Healy is just a clone of existing devices), it’s all the other nonsense medical claims being made about the device.
Oops, sorry. It was the pamphlet I got that said the Healy isn’t backed by current medical standards. I didn’t see it on the website.
No doubt I have an old pamphlet as I didn’t see the FDA claim on it.
Hello people.
Healy is coming in France. People told me about this device, since a have chronic pain (Fibro…).
I was invited to a Zoom présentation to introduce the item.
All the presentation, and information I can found, I do not see difference with TENS device, and where this “company” is using a trick, it is that tell you that device received a FDA approval, who is true, but only for the “Transcutaneous electrical nerve stimulator for pain relief” part.
So, a TENS like others one…
People who do not heard before about TENS and bye this device, and have some benefits (and they will since large companies work a lot for developing TENS programs for pain (like QUELL who I have heard that is a good device, but not delivered in France yet…)) and payed it 500-1000 bucks, they will upgrade their device (in fact it is the same device, it is only access to more programs).
The trick is a shake between TENS device with real effect, and placebo for people who are catched by the trick. If I have some benefits with 500-1000€, if I put 1000-2000 more, I will have more benefits, and the placebo effects starts to works for some people.
And where the company is fine, is that disclaim that for the TENS part, it is approved by medical, and for the rest, it is on your own responsability or “sensitivity”…
So, if someone try to bring them in justice, they are protected by this disclaim…
This is a personal interpretation, with information I can found.
I was informed before about TENS device on chronic pain. I try to find real information about Healy, and all sends nowhere. Fondator and other people mentioned are only knowed on the Healy circle. Quantum physics and mirror quantum told on they speech are totaly BS physics and no serious work on this items can be found.
So, keep your money, and prefer to buy a device who is sold to what it is designed, TENS.
You can found some information here:
practicalpainmanagement.com/treatments/complementary/pain-therapy-options-home
Best regards