The FDA information is consistent with the listed ASIN information, but HAQM still rejected the product because the FDA 510(k) provided does not cover this product
I really hope that HAQM can give me some clear guidance and insights as soon as possible.
Because my product has been shown as unavailable for sale for a long time, this has had a huge impact on my inventory and account.
My listing was deactivated. HAQM marked it as a medical device for professional use. 510(k) and other supporting documents are required to prove that this product is allowed to be sold on HAQM.
Case id 17612890941
Here is the information we provided.
(1) Photos of the 6-sided image of the product packaging
(2) Product manual
(3) 510(k) Number issued by the FDA for this product
(4) Agency Registration Number
(5) Device Name shown by the FDA
(6) Purchase invoice
Although we tried our best to explain that our product is not a medical device for professional use, we still received a rejection from HAQM.
The reason for the rejection was "the FDA 510(k) provided does not cover this product"
This is very sad for me. I tried to ask the review team what information is wrong? We can explain and verify, but the review team still rejected me for the same reason.
I am really sad because this is really important to me.
Because of the problem of unsalable products, I have too much unsalable inventory and my account has also received relevant performance.
I really don’t know which information is missing or incorrect. I feel that I am in trouble.
Any suggestions, contact information or upgrade channels will be greatly appreciated.
I can only ask for help and hope to solve my problem. Thank you very much!
@Manny_HAQM
@Atlas_HAQM
@Emet_HAQM
The FDA information is consistent with the listed ASIN information, but HAQM still rejected the product because the FDA 510(k) provided does not cover this product
I really hope that HAQM can give me some clear guidance and insights as soon as possible.
Because my product has been shown as unavailable for sale for a long time, this has had a huge impact on my inventory and account.
My listing was deactivated. HAQM marked it as a medical device for professional use. 510(k) and other supporting documents are required to prove that this product is allowed to be sold on HAQM.
Case id 17612890941
Here is the information we provided.
(1) Photos of the 6-sided image of the product packaging
(2) Product manual
(3) 510(k) Number issued by the FDA for this product
(4) Agency Registration Number
(5) Device Name shown by the FDA
(6) Purchase invoice
Although we tried our best to explain that our product is not a medical device for professional use, we still received a rejection from HAQM.
The reason for the rejection was "the FDA 510(k) provided does not cover this product"
This is very sad for me. I tried to ask the review team what information is wrong? We can explain and verify, but the review team still rejected me for the same reason.
I am really sad because this is really important to me.
Because of the problem of unsalable products, I have too much unsalable inventory and my account has also received relevant performance.
I really don’t know which information is missing or incorrect. I feel that I am in trouble.
Any suggestions, contact information or upgrade channels will be greatly appreciated.
I can only ask for help and hope to solve my problem. Thank you very much!
@Manny_HAQM
@Atlas_HAQM
@Emet_HAQM
2 replies
Manny_HAQM
Hello @Seller_TBxQTSAdGiDu2,
Thanks for posting to the forums. I've reviewed the details of case 17612890941 and see that you've closed it. Please reopen the case and include the information the team has requested regarding the 510(k). You will need to provide the correct 510(k) number that covers this product and they will review it.
Regards,
- Manny