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.