Correct FDA 510(k) Rejected Thrice - Always the same templated advice
Hi everyone,
We’re reaching out to see if anyone has faced a similar issue or has any insight that could help us.
Case ID: 17580444811
Our listing was recently removed by Amazon on the grounds that our product is classified as a medical device for professional use. They requested documentation to verify the product’s FDA compliance.
We provided everything Amazon asked for, including:
✔️A valid FDA 510(k) number that does cover this product
✔️Clear photos of every side of the packaging
✔️Product manual
✔️Screenshot and link to the FDA 510(k) record
✔️Original invoice from the manufacturer
Despite this, Amazon keeps sending the same templated response saying:
> “The FDA 510(k) provided does not cover this product. The seller’s product may not be unrestricted. Product images uploaded on the detail page do not match with the FDA 510k.”
We’ve verified the 510(k) number is correct, matches the product, and is publicly listed on the FDA site. Yet every appeal gets the same copy-paste rejection.
We’re extremely frustrated and stuck. Has anyone successfully appealed a similar case? Is there a way to escalate beyond seller support or get a real human review?
Any help or direction would be greatly appreciated.
Thanks in advance!
Correct FDA 510(k) Rejected Thrice - Always the same templated advice
Hi everyone,
We’re reaching out to see if anyone has faced a similar issue or has any insight that could help us.
Case ID: 17580444811
Our listing was recently removed by Amazon on the grounds that our product is classified as a medical device for professional use. They requested documentation to verify the product’s FDA compliance.
We provided everything Amazon asked for, including:
✔️A valid FDA 510(k) number that does cover this product
✔️Clear photos of every side of the packaging
✔️Product manual
✔️Screenshot and link to the FDA 510(k) record
✔️Original invoice from the manufacturer
Despite this, Amazon keeps sending the same templated response saying:
> “The FDA 510(k) provided does not cover this product. The seller’s product may not be unrestricted. Product images uploaded on the detail page do not match with the FDA 510k.”
We’ve verified the 510(k) number is correct, matches the product, and is publicly listed on the FDA site. Yet every appeal gets the same copy-paste rejection.
We’re extremely frustrated and stuck. Has anyone successfully appealed a similar case? Is there a way to escalate beyond seller support or get a real human review?
Any help or direction would be greatly appreciated.
Thanks in advance!
16 respuestas
Seller_ohmoB64x0VutY
please review. Thank you so much
@Manny_Amazon@Emet_Amazon@Atlas_Amazon
Glenn_Amazon
Hi there @Seller_ohmoB64x0VutY,
I'm sorry you are having difficulties with this appeal. In general this message means that the information on the Detail Page cannot be tied to the information provided from the FDA 510(k). You will need to demonstrate that the product is the same product on the 510(k) as the product you are offering. I'd make sure that you review all your contributions, including the manufacturer to ensure that all the information is correct and shows the 510(k) relationship.
If you are unable to proceed after attempting to demonstrate this relationship I can attempt to escalate further. Thank you for your understanding.
-Glenn
