Is a massage chair a medical device?

"Is this actually a medical device?" We get asked this question regularly, usually by customers who have been dealing with back pain for years and want to know if there's more to this chair than just a comfortable piece of furniture.

The answer is curious: For the exact same armchair, the answer is “yes” in Japan and “no” in Germany. This page explains why that is and what it means for you.

The short answer

It depends on where you are. In Japan, a massage chair is a Class II medical device, officially registered under its own identification numbers and bearing a certification number on the unit. There, a certified chair may be advertised as having specific effects, such as relieving fatigue, promoting blood circulation, and relieving muscle tension. The country has regulated massage devices in this way for decades, which is tied to its history. In Germany, there is no comparable procedure. Here, massage chairs are classified as electrical appliances and bear a CE mark, which certifies safety but not efficacy. Although a manufacturer can register its device as a medical device in the lowest class—and is then personally liable for it—this is not verified by any independent body. For you as a buyer, this means one thing above all: the label alone says nothing about what a device will actually do for you. What a device actually does is documented in studies, not in government registries.

In Japan: a medical device with a registration number

Japan has regulated massage devices as medical devices for decades. The relevant authority classifies them as 管理医療機器, which translates roughly as “controlled medical device,” corresponding to Risk Class II. Electric massage devices, air pressure devices, and heat therapy devices each have their own classification codes and must meet a series of technical standards, including requirements for risk management and fitness for use.

What’s more interesting than the technology itself is what follows from it: In Japan, there is an officially established list of intended uses for which a certified device may be advertised. Anyone who wants to use these phrases must obtain certification. Each certified device bears a 16-digit number for this purpose, which is printed on the device itself or on the packaging. Japanese buyers are advised to check for this when making a purchase.

There is a historical reason why this system exists there. The massage chair was invented in Japan in 1954 by a company that still manufactures chairs today. You can read about how this came to be in our article “Who Invented the Massage Chair?”

And in Germany?

This procedure does not exist here. Massage chairs are electrical appliances; they must be built to safety standards and therefore bear the CE mark. This mark indicates protection against electric shock, the materials used, and stability—it says nothing about any effects on the body.

A manufacturer may register its device as a medical device in the lowest risk class. In that case, the manufacturer prepares technical documentation, demonstrates compliance with the requirements, and assumes liability for it. An independent body does not conduct inspections for this class.

However, anyone who takes this route makes life harder for themselves, not easier. In Germany, medical devices are subject to the Law on the Advertising of Medicines, which sets stricter limits than general competition law. This classification therefore entails more obligations than freedoms.

Is the difference in the body?

As you read, a question comes to mind: Is a Japanese back built differently than a German one? It isn’t. The spine, muscles, and nerve pathways function the same way in Osaka as they do in Stuttgart, and a roller that glides two fingers’ width alongside the spine does the same thing there as it does here.

The difference lies in the regulatory approach. Decades ago, Japan decided to classify massage devices as medical devices, requiring testing, an approval number, and a fixed list of what manufacturers are permitted to claim. Europe did not take this approach and treats the same devices as electrical appliances. This is a decision regarding how these devices are tested and how they are advertised.

What does this mean for you? Legally, nothing. A Japanese approval is not proof of efficacy in Germany, and we expressly make no claims regarding efficacy here. What a massage chair does for you is not determined by a registry.

Rather, there are two things to consider: what was investigated and your own back. We’ve compiled the first—including details on who paid for each investigation and the four documented cases of injury. You can test the second one with us. You’ll find links to both below, and both will tell you more than any government statistic ever could.

What This Means for Your Purchase

Three things can be deduced from this.

First: Approval status does not constitute proof of effectiveness. What a massage chair actually does is documented in studies, not in government registries. We have compiled a list of the relevant studies on the “Studies on Massage Chairs” page, including information on who funded each study.

Second: Carefully review advertising claims that refer to regulatory authorities. An approval is always valid only in the country that issued it and for the device that was tested there. It cannot be transferred.

Third: Japanese certification provides insight into testing requirements and building codes. It explains why Japanese manufacturers describe their devices differently than European ones. That is all it tells us.

There’s one thing no one can do for you: trying out the chair. Whether the rollers hit your shoulder or miss it by two fingers’ width depends on your height and the position of your pelvis. Your body will sense this within the first two minutes, and no certification number in the world can take this test away from you. In our showrooms, every chair is set up just for that: places to try them out.

Sources

• Pharmaceuticals and Medical Devices Agency (PMDA), Database of Certification Standards for Electric Massagers, Air Massagers, and Heat Massagers. View database
• European Commission, Fact Sheet on Class I Medical Devices under Regulation 2017/745. View fact sheet

You can find an overview of all the studies analyzed—including their design, number of participants, and results—on the " Studies on Massage Chairs" page.

This article provides an overview of the regulatory status of massage devices and is not intended as legal advice. It does not make any claims regarding the effects a specific device may have on you.