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.
Cozzia and Ogawa are built in the same factory in China and are essentially the same company here in the USA. Their operations, both administrative and logistics, are consolidated at the same California addresses. We began carrying the Ogawa line of chairs at about the same time that we opened our Southern California showroom.
The Ogawa Smart 3D massage chair was introduced shortly thereafter and quickly became their flagship model. It was unique in that it used a Samsung tablet as the wireless remote control through the Ogawa app. So, you could use the tablet to run your massage chair AND for all the other functions that one would ordinarily use a tablet computer, i.e. download other apps,etc. It was very versatile for the user. The remote also connected wirelessly to the chair’s speakers. The Ogawa Smart 3D also had a strong dual roller massage, foot rollers, plenty of airbags, Bluetooth connectivity, and it could handle a taller and bigger body.
The chair seemed to capture the imagination of a certain percentage of our customers. I know it captured mine! After a number of sales, we had one of our customers mention to us that he was having trouble getting his tablet to connect to his chair through his Wifi. Ogawa replaced his tablet to rectify the problem, but the problem persisted. It became evident that the function of the chair was tied, of course, to the quality of the Wifi connection. Bad/spotty connection = bad/spotty chair functionality. Of course, you could still use the chair’s hardwired quick keys, but they did not offer all the functionality that the wireless app offered. Our customer became quite frustrated and eventually exchanged the chair for another model altogether.
We brought his model to our showroom and it worked fine…in other words, we had a better Wifi connection. Over the last year or two we have had a few other complaints about the same connectivity issue. The chair worked for most, but for a few it was not what they wanted to deal with. We still have our floor model in our California showroom and it’s working fine. We also found out that replacing a bad tablet was quite expensive ($250 charged to us by Ogawa) and that it did not fall under the warranty of the Ogawa chair, but rather under the Samsung warranty. Hard wired remote controls seem more durable plus they cost considerably less if they go bad and need to be replaced.
Late last year, just prior to the holiday buying season, Ogawa introduced the new Touch 3D massage chair, which is a similar chair to the Smart 3D, but with a hard wired remote and not a wireless tablet. I think this is a wonderful substitute for the Smart 3D and you aren’t sacrificing too much by getting it. Here are the similarities and differences:
At the time of this article, the Touch 3D is $1500 less than the Smart 3D massage chair.
Same silhouette. In other words, the chairs look exactly the same, except for color options.
Different remote controls, i.e. wireless Samsung tablet vs. hard-wired Ogawa touchscreen remote control.
The Smart 3D has adjustable shoulder airbags, both width and height; the Touch 3D airbags are in a fixed position.
The Smart 3D app is upgradeable for new features and programs and is also full of information for the chair, like the owner’s manual, an FAQ section. The Touch 3D does not have the app.
The Smart 3D has 17+ custom programs; the Touch 3D has 9 auto programs.
The Smart 3D utilizes 12 massage techniques through it’s rollers, but the Touch 3D has a more traditional set of 6 massage techniques.
The Smart 3D has the quick keys for manual operation of the chair, which is something the Touch 3D does not need since it uses a hard-wired remote control.
The ottoman of the Smart 3D adjusts electronically; the ottoman of the Touch 3D is spring loaded.
Something that is more subtle and hard to quantify is the feel of the rollers. The Smart 3D has a more smooth and “luxurious” roller massage, as opposed to a little less sophisticated roller mechanism of the Touch 3D.
I hope you found this comparison useful. Both chairs were equally popular during the holiday sales season.
Dr. Alan Weidner
P.S. Give us a “Like”, “Share”, or “+1” and leave me a comment or question below to share what you learned or ask any questions, so other folks can benefit from this material.
Transcript of Video Titled “Massage Chair Industry Update – March 24, 2016”
Alan: Hi, I’m Dr. Alan Weidner from ‘Massage-Chair-Relief.com’ and today is our biweekly massage chair industry update for Thursday, March 24th, 2016, and not a whole lot to talk about today. Of course, I always say that, and I end up yakking forever, but here’s the things that we’ve got cooking.
[SCREEN TEXT: Stock Status]
Alan: Let me get in to stock just briefly. I emailed the massage chair companies last night for information about their stock, and the only one I heard back from was Infinite Therapeutics, so – or Infinity now, as they’re more commonly known as, they have the – oh, and then Human Touch also notified me that the WholeBody 5.1 is out of stock. They didn’t have an estimated time of arrival of the new models. So, that’s the Human Touch WholeBody 5.1. They discontinued the ZeroG 2.0, and I think they’re also discontinuing the Human Touch 7450, so there are some changes there. Now, Infinity, they’ve discontinued the ‘Ivory’ IT-8500, they’ve discontinued the Iyashi, white exterior with the caramel interior, and they’ve discontinued the IT-8100, but I’m going to talk about a new model that they just introduced, to kind of replace that one, and I’ll talk about that in a moment, and also, the black on black Iyashi is just on back-order. So, that’s the only chair they have on back-order, and that’s back-ordered for two to three weeks. As far as Inada goes, I think they’re all in stock there. I haven’t heard of any other Human Touch chairs that’re back-ordered. Osaki, Titan, and, Apex, I never really quite know until I place the order, if they’re back-ordered. I believe the Ogawa chairs are all in stock. I think the Ogawa Refresh was back-ordered until the middle of March, I believe that’s in stock now. So, anyway, if you have any questions about stock at the time of purchasing any particular model, let us know, and I will say that sometimes we think that they’re in stock, or that we’re told that they’re in stock, and then you know, a week later, someone places an order, and then we send the order in, and they tell us ‘Oh, that’s back-ordered.’ Well, sometimes they don’t know fully if the chairs are back-ordered or not, at the moment – well, let me put it to you this way – at the time that they tell me that they’re stocked, or not stocked, I believe that, but the stock could disappear in a day or two, or three, or four after I do this recording. So, a week from now, the stock may be gone, and we’ll let you know if the stock, if it’s back-ordered, and usually it doesn’t take longer than one or two weeks, except for the Infinity Escape, which took like two-and-a-half months. January, February, oh my goodness, yeah, we didn’t – we got it, January, February, half of March – yeah, it was two-and-a-half months. That’s rare, that’s very bothersome to me as a retailer, and very bothersome to my customers, but sometimes that happens. So, anyway, having said that, let’s move on.
[SCREEN TEXT: New Infinity IT-8500X3 & Infinity Evoke]
Alan: Infinity, now, I told you that they were discontinuing – or that they discontinued the IT-8100 – well, they’ve made a couple of exciting announcements, one of which is very interesting to me. The Infinity IT-8500, I don’t know if you’re aware of this, but the Infinity IT-8500 is a Chinese-made chair, all the Infinity, and Osaki, and Human Touch, they’re all Chinese chairs, but their chair, the IT-8500, has been our top selling Chinese chair for as long as I’ve been selling it. I figure that’s probably five, maybe five years, and our top selling Chinese brand, or Chinese model, made model. It just continues to be a popular chair, and the one thing that it lacked, in my humble opinion, was – it was a – it didn’t have the 3D rollers. Well, people were fine with that, because, and I’ll talk about this a little later as well, as far as adjusting intensity, for a chair that does not have 3D rollers, but this chair, the IT-8500, very popular chair, good bang for the buck. It was priced, for the longest time, at $3995. Now, it’s $4295; still a very good price, for a good feature set in a chair. Well, they’ve come out now, with the new IT-8500X3, and that has – and the X3 alludes to the 3D technology – so it has the same fit, and same body. I’m just looking at the thing here, excuse me, the spec sheets, and let you know what they have. They’ve got new 3D auto programs, they’ve got an auto extend neck feature, they’ve got five 3D intensity levels. Let’s see the chair is going to be selling – it’s going to be retailing for $5795, with a $300 off promo code, so that’s – instant savings, that is, so it’s $5495. So, it’s going to be $1200 more than the IT-8500, which will have the – but it’ll have the 3D rollers, it has – oh, it says here also, it has the Bluetooth compatibility. You know, the 8500 has the older, you know, download your music to a jump drive on your computer, and then plug it in to the USB port in the back of the IT-8500. Well, now it’s going to have Bluetooth connectivity, which is great because you can just connect from your cell phone, and play your music. It has a sleeker, redesigned remote, so I don’t know what sleeker looks like, but I know the remote right now, it’s a fairly, good rectangular shape. It’s a good size, easy to see, but we’ll see how it looks, and it still has the decompression stretch, and spinal alignment. They call it spinal alignment, it’s the shoulder airbags that pin the shoulders back. The stretch program on the IT-8500 is awesome, the neck massage, awesome, foot rollers, awesome, it’s a great chair. So, I’m very curious to see how this new IT-8500X3 is, and I’ll let you know once I find out more about it. I’m sure we’re going to get it in one of our showrooms – but one, maybe both of our showrooms – but definitely we’ll have it in the California showroom. Anyway, there’s another new model they’re sending out, or introducing now, to the market, called the Evoke, E-V-O-K-E, Evoke, and here are the basic features – and again, I’m sorry for not looking at the camera, I’m just looking at the stat sheet that they sent me – zero gravity, deep tissue massage, space saver, airbags from head to toe, well, everybody seems to have that, lumbar heat, foot rollers, heel rubber, and I think that’s the same thing that they have in their Escape, which is their lower priced L-track chair. And that heel rubber kind of – it’s a great foot massage – and I don’t know if it’s going to have the same six rollers per foot that the Escape has, but the heel rubber is pretty cool, as it grabs the heel, and gives that a massage. So, anyway, that’s the Evoke, and that one’s going to be selling for $2695, so it’s going to compete price wise, with the Osaki 4000T. The Osaki 4000T is a real – it’s a workhorse, it’s been around forever – it doesn’t fit some people very well. I’ve found that the Osaki 4000T, and probably the 4000 that you can get on Costco, the Dreamer, the Osaki Dreamer, and the Osaki 7200H, and 7200CR, they have shoulder airbag housing that’s a hard stop, and so what’ll happen is when you sit in the chair, and then you put your arms out, to go in to the armrests for airbag massage, the bottom of the housing, the shoulder airbag housing, digs in to your upper arms, and it can be quite uncomfortable. It’s worse on the Osaki 4000T, and the Osaki 4000, not as bad on the Dreamer, or on the 7200 series, but it is burdensome for a large, broad-shouldered person to sit in that bloody chair, it becomes irritating. Well, this is a chair, $2695, that kind of competes with the 4000T. It has the deep tissue massage, the 4000T is the more moderate, mild massage, this Evoke seems to be more deep tissue. It’s a space saving technology, none of the Osaki 4000, or 4000T models, have it, lumbar heat, foot rollers, the foot rollers on the Osaki 4000T are pretty mild. I suspect with Infinity, knowing their other chairs, it’s going to be a good, intense foot massage. Anyway, that’s the new Evoke, so I don’t know if I’m going to be having that in my showroom either, maybe I will. The 4000T is kind of an older technology, it’s been around for years. That’s kind of – that was the flagship chair for the Osaki brand, and then, of course, they’ve now got so many other models, and model – brand lines, and you know, whatever, so anyway, just so that you know.
[SCREEN TEXT: Update on the SoCal Showroom]
Alan: Alright, what else have we got cooking? Let’s see, oh, our Southern California store, I was just down there last week. We were doing some recording for a television commercial. Well, our walls are still as bare as the day is long, I mean, and they’re long walls. So, the guy that did our buildout is going to put up some sconce lighting for us, and some nice trim, and we’ll put up some pictures, and you know, we’ll have Mona kind of pick some nice artwork, or whatever, or maybe some nice pictures of massage chairs, heaven forbid, and we’ll put that up on the wall to kind of make the wall look a little busier. But I’ll take the videotape of that when we have that done, and it’ll look sharp, but we’ll post that up for you to take a look at, but that Southern California store is a nice store. I like it, it’s wider than our store here in Utah, it’s deeper than our store here in Utah. You feel like you can have more than one person in there at a time, looking at chairs, but I really like that store, great store, and great staff. So, go down and meet Michael and Chris, they’re just awesome, and for those of you that don’t know, and of course, if you’re only Vietnamese speaking, you’re not going to understand a word of what I’m saying now, but Michael Nguyen is our showroom manager, and he’s bilingual, Vietnamese and English. And so, you know, feel free to give us a call at that – at our, well, here – our number there is 562-865-4607, 562-865-4607. Go ahead and call, and you can talk to Michael, if you’re Vietnamese, of course, talk to him, but for Anglos, you can talk to Michael or Chris.
[SCREEN TEXT: Massage Chair Tip!]
Alan: And one last thing I’ll chitchat about, just – you know, I should do this every one of these video recordings – these biweekly updates, I should give like a massage chair tip, or something like that. But one thing that people – I tell people, all the time, about in our showroom is how to use – how to change the intensity of a massage chair if it’s too intense for you, and you don’t have the 3D rollers. Even if you do have 3D rollers – by the way, 3D rollers mean that the rollers can move forward or back to increase, or decrease, the intensity of the massage – well, what do you do if the lowest intensity setting of the 3D roller is still too much? Or, what do you do if you’ve got a chair like the IT-8500, which is a deep-tissue massage chair, but it doesn’t have the intensity adjustment ability, it doesn’t have the 3D rollers, or now it does, but if you can’t get it low enough? Well, what we always recommend is using something that we call a throw blanket. Now, I don’t know if you know what a throw blanket is, but a throw blanket is like a decorative blanket that a lot of people use for, you know, to decorate a couch, or a chair, and these massage chairs aren’t the prettiest things in the world, so a lot of people use throw blankets to kind of, you know, try to camouflage the chair. But well, you can use that throw blanket, if you fold it up in quarters, or whatever, and you use that as a back pad. It’ll, you know, lay it down the length of the chair, and use that as a back pad. It’s a wonderful way to do it, because sometimes people use pillows, like sleeping, bed pillows, or couch, decorative pillows. They’re too thick, you’re not going to feel much massage at all. So, you know, if you can get a thin foam pad, or something like that, that’d be great, a memory foam pad, like the iRobotics 7 comes with a memory foam pad now, which is great, but just use a throw blanket, it’s awesome. Plus, if you’re the decorator of the house, and you look at that chair, and you go ‘Oh my goodness, that is butt ugly,’ and you want to change the look of it, use a throw blanket for that too. Anyway, there’s my intensity adjustment advice, and my decorative advice, which is so amazing.
[SCREEN TEXT: 888-259-5380]
Alan: Well, I think that just about does it for this week. If you have any questions, feel free to give me a call at 888-259-5380, there you go, and of course, you can always email me, comment on our YouTube channel, or on our Facebook page, or you can go on our chat software, whatever. You can always reach me, and if you don’t get directly to me, I will always call you back, but anyway, feel free to give us a call. If you found this video helpful, please feel free to thumbs up ‘Like’ us on YouTube, and of course, share this, or any of our other videos, on your social media platforms to help us spread the word about massage chairs, we appreciate that. Massage chairs are kind of a new thing, relatively infantile in its stage of development here in the United States, and we appreciate you helping us spread the word about it, because this is a great thing. Duh, that’s why I do it. Well, anyway, I’m Dr. Alan Weidner from ‘Massage-Chair-Relief.com,’ and I will see you in two weeks. Bye bye.