Selling health devices online: FDA clearance, wellness claims and what a listing may say

Two words on a health gadget's listing carry more weight than most: "FDA cleared". Used correctly, they tell a buyer the device went through the FDA's premarket review for a stated use. Used loosely, they are a reason for a marketplace to remove the listing. And a fitness tracker or massager that strays into medical claims can become a medical device in the eyes of US law, with rules it was never built to meet.

This page covers clearance, the wellness line, hearing products, and what Amazon, Walmart, eBay, Etsy, Canada and the EU ask of a health device listing.

What this page covers: health monitors, thermometers, TENS units, massagers with health claims, hearing aids, braces and supports, masks, light therapy and IPL devices.

The short version

• Many devices need FDA clearance, the 510(k), before they are sold, and may be promoted only for their cleared use.
• A low-risk product stays outside device rules only when it is promoted for general wellness alone.
• "FDA cleared" and "FDA approved" are different, and either is allowed only when true.
• Prescription devices are barred on eBay and limited on Amazon.
• Canada and the EU have separate approvals: a Medical Device Licence and CE marking.

When does a health device need FDA clearance?

Many devices need FDA clearance through a premarket notification, known as a 510(k), before they can be sold in the US. Once cleared, a device may be promoted only for the use it was cleared for. Amazon expects Class I and II devices that are not exempt to be FDA cleared, and asks sellers to use "FDA cleared" and "FDA approved" correctly. Walmart allows either phrase only when it is true and bars FDA logos.

Two practical points follow:

• If your device was cleared for one use, describe that use and no other. A TENS unit cleared for muscle pain relief is not a treatment for another condition because a buyer says it helped.
• Never put an FDA logo on an image. Walmart bars them outright.

When does a wellness product become a medical device?

A low-risk wellness product becomes a medical device when it is promoted for more than general wellness. Low-risk products such as fitness trackers can stay outside the device rules when they are promoted only for general wellness: staying active, sleeping well, managing stress. The FDA revised its policy on 6 January 2026, and for wearables it turns on how the product is advertised.

That makes the listing the deciding document. "Tracks your sleep" is a wellness claim. "Detects sleep apnoea" is a medical one. The same device, described two ways, falls under two sets of rules.

How do hearing aids and sound amplifiers differ?

Over-the-counter hearing aids are for adults with perceived mild to moderate hearing loss. A sound amplifier is a different product and may not claim to treat hearing loss. If your product is an amplifier, say what it does, which is make sound louder, and leave hearing loss out of the title, bullets and images.

What should a health device listing leave out?

A health device listing should leave out disease claims, uses beyond the cleared one and FDA logos, in words and in images:

• Disease claims. Etsy prohibits items that claim to treat, prevent, cure or diagnose a disease.
• Uses beyond the cleared one, in words or in images. An image can make a claim too: a device shown on a medical chart or beside a diagnosis says what words would say.
• FDA logos, anywhere.

What does eBay ask a health device listing to say?

eBay asks the description to say whether the device was opened or used, and to give its expiration date.

What does each marketplace ask of health devices?

Amazon, Walmart, eBay and Etsy each add rules for health devices:

What do medical devices need in Canada?

Class II to IV medical devices sold in Canada need a Medical Device Licence.

What do medical devices need in the EU?

Medical devices sold in the EU need CE marking under the Medical Devices Regulation.

How Commicorn helps

• Claims that need proof are marked. For Amazon, the keyword step shows a keyword such as "FDA cleared" with a line saying a valid certificate is needed, so you see the condition before the phrase goes into your listing.
• Your packaging, as printed. On the Untouched product route your photo's pixels are never redrawn, so the indications for use on your box stay exactly as printed.
• You confirm the use. The listing copy is written from the details you give us. Read each line against your device's cleared use before you export.

Questions sellers ask

What is a 510(k)?

A premarket notification to the FDA that many devices need before they can be sold in the US. Once cleared, a device may be promoted only for the use it was cleared for.

Can I call my device "FDA approved"?

Only when it is true. Amazon asks sellers to use "FDA cleared" and "FDA approved" correctly, and Walmart allows either phrase only when it is true and bars FDA logos.

Is a fitness tracker a medical device?

Not when it is promoted only for general wellness, such as staying active, sleeping well or managing stress, under the FDA's policy revised on 6 January 2026. "Tracks your sleep" is a wellness claim; "detects sleep apnoea" is a medical one.

Can I sell a CPAP machine on eBay?

No. eBay prohibits prescription devices, including CPAP machines, prescription pulse oximeters and glucose monitors, contact lenses and prescription TENS units.

Do I need a licence to sell a medical device in Canada?

For Class II to IV devices, yes: a Medical Device Licence.

Before you list

Have the device's FDA clearance and its cleared intended use in front of you before the listing goes live, and read every title word, bullet, keyword and image against that use. For eBay, add the opened or used status and the expiration date; for Canada, the Medical Device Licence; for the EU, the CE marking. On a borderline gadget, two things settle it: whether the FDA's general wellness policy covers the way you promote it, and the marketplace's medical device policy, both linked below.