If you have read any of my articles or watched any of my Massage Chair Industry Update videos in the past, you know that there are certain things that I consider my "pet peeves" in the massage chair industry. Topics like 4D vs. 3D massage chairs, chromotherapy, and no-name brand marketing tactics. Well, the subject of "FDA Approved" massage chairs is another one.
FDA & Medical Devices Background
The Food and Drug Administration (FDA) has specific grading standards and protocols in place to determine if a new medical device or product, that claims a health benefit, is a Class I, Class II, or Class III product and, thus, requires FDA approval of that product for the US marketplace and consumer. Of course, these grades and approvals are designed to make sure the products are safe and do not pose a potential danger or threat to the American consumer. They are in place to protect you and me.
According to www.fda.gov, examples of Class I devices present minimal potential harm to the user and include products like "enema kits and elastic bandages." Examples of Class II devices include "powered wheelchairs and some pregnancy test kit" and have a higher risk. Class III devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. They can include products like "implantable pacemakers and breast implants."
95% of Class I devices are "exempt from the regulatory process" and, thus, do not require FDA approval. 10% of medical devices are considered Class III do require the FDA approval. 43% of medical devices fall under the Class II category. Some of them require FDA approval and some don't.
What Does FDA Approval Entail?
Approval involves notifying the FDA with the intent to market a Class III and, in some cases, a Class II medical device. Those companies seeking approval must first submit a PreMarket Approval (PMA) application or 510(k). The FDA will determine if the medical device seeking approval is "substantially equivalent (as safe and effective) to a device already on the market." If the device is considered "substantially equivalent", then the manufacturer can market the device. If it is not, then the approval process continues.
Massage chairs are considered Class I devices, therefore they DO NOT require FDA approval. They do not require a PMA or 510(k) application. If you see any advertisement from any massage chair company that says "FDA Approved", rest assured you are seeing a classic example of false advertising!!
FDA Approval vs. FDA Registration (a big difference!)
Now, let's talk about "registration" of a product with the FDA, which is not an "approval" by the FDA. From what I got in my research (online search and phone conversation with an FDA medical device rep), any medical device can be registered by a manufacturer or a US rep for a foreign manufacturer. Registration is a simple process that involves divulging information about the company submitting the registration, submitting the products that are being registered, and an annual renewal fee.
I went through the www.fda.gov site and searched for massage chair company registrations. I saw Family Inada, Human Touch, Luraco Technologies, Infinity, and Osaki Titan as listed massage chair companies. I also saw the manufacturing plant for the Cozzia and Ogawa (and, I assume Fujimedic) massage chairs. So, from what I gathered by reviewing those registrations, either the US distributor of the massage chairs or a US contact person for a foreign manufacturing facility can register the medical devices.
The Bottom Line
The bottom line is this: there are no massage chairs that are FDA Approved for the simple reason that they are Class I medical devices and do not require FDA Approval to be marketed in the USA. However, massage chair companies can and do register their company and their medical devices with the FDA by paying a fee and renewing that fee annually. That DOES NOT mean their chairs are FDA Approved. They are quite simply just registered with the FDA. I would say it's safe to say that most, if not all, massage chair companies in the USA are registered with the FDA. So, when you see a company state that it and it's products are FDA registered, know that most are and it is nothing unique to that company or products.
So, if you see an advertisement of a massage chair that says "FDA Approved", just know that it is false advertising and completely misleading. Don't be afraid to call out companies that do that! Also, if you see an advertisement of a massage that says "FDA Registered", know that most, if not all, already are. If you doubt the veracity of their claim, just ask for their registration number and you can look it up on www.fda.gov.
Dr. Alan Weidner
P.S. Give us a “Like”, "Share", or "+1" and if anyone would like to shed more light on the subject, please feel free to comment below. I am certainly not an expert on FDA approvals, but hopefully this article will get a conversation going.