My product is not a medical device, but Amazon keeps repeating the same response its medical device, labeling it as one.
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?
4 replies
Glenn_Amazon
Hi there @Seller_lGY3x0hAXbAQ1,
Thank you for your patience. I've reviewed your case and at this time the team is currently investigating this product to see if the product can be reinstated. It can take up to 10 days or more for a review to complete. If the investigation isn't completed within 10 days please reach out to me here and I can see what I can do to escalate this issue further.
Regarding your product being identified as a medical device, there are many factors that might contribute to your product being identified as a Class III medical device. At this time the best course is to wait till the team completes their review. Thank you for your understanding.
-Glenn
