Not a Medical Device
Hello,
We are having issues with our product being classified as a medical device. We have sent countless appeals and provided all the documentation that Amazon has requested, but they still seem to want to classify our device as a "powered inflatable tubular medical device."
Our product is similar to other products sold on Amazon which do not have a 510(K) number according to the 510(K) database.
Could we please get some assistance from the mods? We are unsure who to contact. It seems that Seller Support are not looking over the documents we provided as proof that our product is not a medical device and does not require a 510(K) number.
Below are our Case IDs:
14836607551
14825935741
14825752031
14836450651
14870784371
Thanks in advance,
6 replies
Seller_rI7BZIczK8iAC
In spite of countless appeals you insist. You have to be new on Amazon! If Amazon decides something, you can prove whatever you want, they won't change opinion. Try to sell on another platform.
LeviDylan_Amazon
Hello @Seller_P8gVqUFJOwadP,
Thank you for reaching out on the Seller Forums.
From you have posted, I see that you are facing issues with restricted products specifically for medical devices. Typically, a listing can be flagged due to keywords in the listing or the item itself may be prohibited. Have you identified that the keywords may have been the issue? If so, have you made the edits to the listing before submitting your dispute? If you are submitting a dispute to prove that the item is not classified as a medical device, and the listing still contains those keywords, then the dispute may be denied until the edits are made. If the product does not require a 510(k) you will be asked to provide an explanation with proof that your specific item has a 510(k)-claim exemption. What type of supporting documents are you submitting in the dispute?
I look forward to learning more, so that we can assist you the best. Please feel free to post updates in this thread, and remember, the Forums community and I are here to support you.
Wishing you the best,
LeviDylan
