From time to time, we have customers who ask us if our massage chairs are FDA Approved. They ask because they see some of the massage chairs on the market advertising their chairs as "FDA Approved". In a short summary, we suggest Buyer Beware if you encounter any massage chair companies who advertise with this label because it is misleading and in our opinion, it is unethical marketing practice. This type of misleading practice can most often affect the most vulnerable consumers in our market to make bad financial decisions. We do not support this type of business practice even if we lose a customer.
If you are interested in learning more details, please keep reading.
FDA (Food and Drug Administration) classifies medical devices into three risk classifications: Class I, Class II and Class III.
Class I are devices with the lowest risk such as nonelectric wheelchairs and even manual toothbrush. Massage chairs are classified as Class I medical product according to FDA (Link).
Class II are devices with slightly higher risk than Class I such as blood pressure cuffs and pregnancy test kits.
Class III are devices with the greatest risk. Class III devices usually sustain or support life and often implanted. Examples of Class III devices include implantable pacemakers and breast implants.
What is FDA's requirement for Class I medical devices?
According to FDA's website, massage chairs are Class I devices and they are 510(K) exempted. This means that it does not require any premarket notification or approval (Link). We have provided you a direct link to FDA so you can read for yourself that massage chairs does not require "Premarket Notification (510(K)) or "Premarket Approval (PMA)".
Class III devices are only devices that require FDA premarket approval either through 510(K) or PMA. These requirements are to ensure they are safe and effective based on FDA's regulatory guidelines.
Class I and II devices DO NOT require FDA approval.
Typically, Class I and II devices do require only a submission of 510(K) Premarket Notification, but massage chairs are exempted. Therefore, you can see that why labeling a massage chair "FDA Approved" is false advertising and even deceptive practice.
Why would you trust any company who is using this deceptive marketing practice?
What else are they marketing about their massage chairs that are deceptive and misleading?
FDA Registration vs FDA Approval?
In addition, do not confuse FDA Registration vs FDA Approval. Pretty much every medical device manufacturer is registered with FDA. This process is a simple process that requires filling out basic information about the company and products and an annual renewal fee with FDA. So if you encounter a massage chair company that is boasting that they are "FDA Registered", please know that this is an insignificant fact. It is meant to sway uninformed consumers who might find this "FDA" label as a badge of medical legitimacy of their massage chair. Most ethical massage chair companies will NOT use this marketing technique because it is also indeed just a cheap marketing trick.
No massage chairs are FDA Approved. They are Class I medical devices and DO NOT require FDA Approval.
FDA Registered DOES NOT mean that they are FDA Approved.
If you see an advertisement of massage chair with label "FDA Approved" or "FDA Registered", please Buyer Beware. They are simply marketing tricks.
When in doubt, look up their company information on www.fda.gov.