FDA Approved Massage Chairs? Really?? Don’t Believe It!

square grunge red fda approved stamp

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

PinocchioThe 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.


16 Replies to “FDA Approved Massage Chairs? Really?? Don’t Believe It!”

  1. do both manufacture and costumer need to register?
    i just checked and their annual fee is $5,546. that is ridiculous!
    all i wanted was buying 20 pcs…

    1. Wow, that is steep! From what I have been told, yes, both need to register.
      dr. w.

  2. what about massage chairs bought from factory in china?
    will the fda prevent me from buying from an unregistered company?

    1. Hi, Shirkhan
      Thank you for your inquiry. The FDA has absolutely nothing to do with any massage chair being shipped to the USA from China. Most brand name companies register their chairs with the FDA, though it is not required. But, if you are purchasing your chair directly from China, there is no need to involve the FDA at all. You just have to deal with customs duty and/or import taxes. That’s about all! I hope this helps.
      dr. w.

      1. Thank you for replying doctor.
        i am asking because a while back i ordered 20 unbranded massage chair,
        and when it arrived to US port i received a “refusal letter” from the FDA saying
        my products are detained and i have 90 days to destroy or re-export. what could be the reasons?

        1. Hi, Shirkhan
          I reached out to a couple of my chair suppliers to ask what is up. Apparently, there are other factors that come into play when you bring products over from China. One of my suppliers said the laws are different for individuals importing than for companies. I don’t know what those laws are but have asked for more input from those suppliers. Anything else I learn I will share with you on this thread. I’m sorry to hear about this dilemma. I have never imported chairs myself so I can’t speak from personal experience.
          dr. w.

          1. The latest I’ve been told is that you have to be registered with the FDA as a US distributor of massage chairs and the factory that is exporting your chairs to the USA has to be registered with the FDA. Not approved, just registered. You might want to look into registering your business with the FDA and also checking to see if the factory that built your chairs is registered. I hope this helps.
            Dr. W.

  3. I just saw a “FDA Class II certified ” massage chair. Is that approved or another term for registered? It was the Zarifa USA Smart Z chair. We’re just looking for a chair we can use FSA and they claim to be that.

    1. Hi, Al
      Thanks for reaching out. There are no massage chairs that are “FDA Class II certified”. I would ask this company to provide a copy of their FDA certification. That would be an industry first, if it was true. A look at their website and I see no mention whatsoever of any “FDA Class II” certification. You’d think that something that huge would be posted all over their website. All massage chairs are Class I devices and require no approval or certification. Pretty much every massage chair is registered with the FDA, but that does not mean AT ALL that they are approved or certified. BUYER BEWARE! Massage chairs, let alone all over the counter massage products, are Class I devices – no approval or “certification” needed.

      Now regarding FSA and HSA payment of massage chairs. We have been telling customers for years to contact their FSA/HSA administrators before making a purchase. Their should be a phone number on the back of your card. Most companies require that you purchase the chair and then submit the receipt to the administrator for reimbursement. I would suggest calling them before you do anything else.
      dr. w.

      1. Thank you for the reply Dr. Weidner, I have contacted the company for a copy of their certification.
        The chair in question is the Z”-Smart Massage Chair” it says “FDA Class II Medical Device” under “Special Features” halfway down the page here:
        I will respond with the company’s response once I hear from them. Thank you

        1. Hi, Al
          Thanks for your comment. I am interested to understand what they mean by “Certified by the FDA as a Class I and Class II (device)”. Does that mean they are registered with the FDA, as are virtually all massage chair companies in the USA? Or do they speak of a special certification that they have received from the FDA? I am also interested in their statement that they are certified as Class I AND Class II devices. Perhaps that applies to other products they carry, other than massage chairs. Comments like these can be very misleading to the public. Please share with us what you find out. Thank you.
          dr. w.

  4. Hi Dr. Weidner, I found your article very helpful. I know you can not give medical advice, but I am a breast cancer survivor and I suffer from increased anxiety because of the Tamoxifen medication that I take to decrease the possibility of recurrence. So, I am in the process of creating a relaxation space in my home and was very excited about purchasing a massage chair until I saw the California Propopsition 65 Warning about chemicals that “may” cause cancer for one of the BestMassage Brand chairs. (Link: https://www.walmart.com/ip/BestMassage-Shiatsu-Massage-Chair-Full-Body-Recliner-with-Heat-Stretched-Foot-Rest/710751678?selected=true)

    Before abandoning the idea of purchasing a massage chair completely, I have been trying to do research to see if there are any chairs that don’t have any the Prop 65 chemicals, which is virtually impossible because the product descriptions do not include the list of chemicals used in manufacturing the chairs. Do you know of any Prop 65-free massage chairs on the market? If not, do you think it’s best to just abandon the purchase to avoid the risk? Again, I know you can’t give medical advice. I just would love to know your thoughts. What would you do? Thank you very much!

    1. Hi, Robin
      I have heard this argument before and, to tell you the truth, I do not know which chairs specifically have these potentially carcinogenic chemicals. I would suggest that chairs with leather upholstery, though the selection is awfully thin, would be a safer bet than the synthetic leather, which I understand to be the culprit. Do all chairs with synthetic upholstery have these chemicals or just a certain type of synthetic compound? I really don’t know but it would be a worthwhile project for us to get a list of the components from the massage chair companies. I have put that on my to-do list. I hope this helps. By the way, the chairs that have leather upholstery include the OHCO M.8 LE and the BodyFriend Pharaoh SII.
      dr. w.

  5. Wow, one would think that something that affects the body as much as a massage chair can and does would need the be somewhat regulated. I’ve set/used a couple I found on display and had to ask for help to get out of them, very uncomfortable and felt almost claustrophobic.

Comments are closed.