My ASIN (B0D62H9FX1) is a healthcare device that provides near-infrared light and bone conduction sound. The FDA has already confirmed that it is a healthcare product, and US Customs verified it with the FDA before allowing it to be imported as a general healthcare device. However, Amazon suddenly removed the listing, claiming that it is a Class III medical device, specifically a cranial electrotherapy stimulator (CES). This case number is 16512063331.

I have provided images, the product manual, and documented communications with the US FDA to prove otherwise. Despite this evidence, Amazon insists that our product is a Class III medical device.

I even explained in detail the definition of a CES, clarifying that CES devices are medical equipment only if they contain electrodes that emit electrical currents for brain therapy. Amazon, however, seems determined to classify our near-infrared device and bone conduction headphones, similar to products like SHOKZ, as medical devices.

When I requested evidence that our product is a medical device, I received the same repetitive response from Amazon each time. It has been 10 days of identical responses, and I’m at a loss for words at this point.

What steps can I take to get my listing reinstated?

Our product is classified as a medical device requiring FDA registration. According to Amazon's requirements, we need to provide a lab-generated label compliance report under 21 CFR Part 801. My key question is: If we obtain the report for one product variant, will additional color variations of the same product require separate reports? Despite opening cases, Amazon support has provided no clear guidance, stalling our product launch.

We have a product that is classified as a medical device and we are being told that we are required to have this UL 4200A testing compliance provided to Amazon. Amazon Seller Support does not seem to understand the difference between items. Just because the product has a button battery, doesn't mean it is regulated by CPSC. Below are the references.

MODERATORS, please assist with this.

This product is a medical electronic thermometer which is defined as a Medical Device per 21 CFR SubChapter H.

This product is not defined as a "Consumer Product" per 15 U.S.C. §2052(a)(5)(h) 2022. The definition clearly states that a "Consumer Product" does NOT include "drugs, devices, or cosmetics (as such terms are defined in sections 201(g), (h), and (i) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(g), (h), and (i)]),).

This product is defined as a "device" and regulated under the Federal Food, Drug, and Cosmetic Act as defined in 21 U.S.C. 321(h)

As this product is a medical device, and not governed by the requirements setforth by the CPSC nor Reese's Law.