My product is not a Medical device and its not tend to be used by professional
Please I need Help! I have 2 listings been removed because Amazon flagged it as a Medical device and its tend to be used by professional ! WHICH IS NOT, It seems like the seller support they not looking to any documents I have sent or reading the statements I made it with evidence from the FDA platform that my product is not even listed there so there is no need for a 510k. Please I need someone to take a second and review all attachments that I sent regarding these cases!!
ID 16570680741
ID 16580707181
My product is not a Medical device and its not tend to be used by professional
Please I need Help! I have 2 listings been removed because Amazon flagged it as a Medical device and its tend to be used by professional ! WHICH IS NOT, It seems like the seller support they not looking to any documents I have sent or reading the statements I made it with evidence from the FDA platform that my product is not even listed there so there is no need for a 510k. Please I need someone to take a second and review all attachments that I sent regarding these cases!!
ID 16570680741
ID 16580707181
5 respuestas
Michelle_Amazon
Hello @Seller_8wWxNpl87oud1,
Thanks for reaching out. I have reviewed both cases that are being reviewed by the Restricted Products team. You will need to provide exactly what is requested from the team. When they ask for all sides of the product, you need to provide all 6 sides, same thing when they ask for images of the packaging. You need to provide all 6 sides of the packaging as well. You need to contact the FDA or show proof that these items do not require a prescription if they don't. Ensure that your product complies with the Medical Device help page.
Once you have provided all the quested information, then they will review again. Without this proof, you will not be able to get these approved. If you still need help after you have provided all requested information, please let me know.
Regards,
Michelle