Hello, Amazon mistakenly considered my product to be a professional medical device and then reversed the decision. Case 15880481751.then I just changed the title of this product, added more keywords and the same thing happened again for the same reason Amazon removed the listing. I sent an appeal a week ago. Case 16054636791. one week passed No one responded please help me.

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?

Hello,

We are having trouble with our far infrared product being classified as a medical device. We have appealed multiple times and provided Amazon’s required exemption evidence, but they still require us to provide a 510(k) number

The deactivation reason is: 1. The product is identified as a high-frequency laser, LED, or other light therapy device for the treatment of acne, which is considered a medical device for professional use only.

2. They believe that the exemption evidence we provided does not include our product

I tried to ask customer service to help me look up the link trigger words, but nothing worked, and they said they didn’t know either. Now I have deleted the medical words I think may be in the description, but it still doesn’t work. Here is the information I have provided:

1. The FDA registration number of the device, showing that the product is classified as a 510k exempt device.

2. Provide pictures of the box and product manual

3. Confirmation letter from the manufacturer that the device is registered with the FDA as a Class I, 510k exempt device

Despite providing all this information, I received a response from Amazon, again requiring 510k clearance. I don't know how to further clarify that this is an exempt device, it is officially registered and does not require 510k clearance.

Here is our case ID: 16655505691

Requesting some pointers from experienced sellers. Can you guys help me with this? Many thanks

Thanks in advance,