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Seller_ZprJMm7kiEhKS

510(k) premarket notification not recognized by amazon

Hi! We're reaching out to the community hoping someone can offer some guidance on a frustrating issue we're encountering.

Our listing was recently deactivated by Amazon, citing it as a professional-use only medical device that requires a valid 510(k) premarket notification.

Case ID: 17494248771

We have submitted the following documentation to Amazon for review:

✅ The relevant FDA 510(k) number

✅ Clear photographs of all sides of the product packaging

✅ Photographs of the complete instructions for use

✅ Our FDA Establishment Registration Number

✅ Letter from the manufacturer

✅ Confirmation that the device name matches exactly as it is listed on the FDA database

Despite providing all of this information, we continue to receive the same generic response from Amazon stating:

"The FDA 510(k) provided does not cover this product. Sellers are expected to provide complete and accurate information in order for us to proceed with our review of this request."

We have meticulously reviewed the FDA database and are certain that the 510(k) number we provided is indeed the correct one for our product. We are feeling stuck and unsure of what additional information Amazon might be looking for or what we might be missing.

Has anyone else experienced a similar situation with a 510(k) review and the recurring canned responses? Any advice on how to break this cycle, specific contacts within Amazon to reach out to, or potential escalation steps we could take would be incredibly helpful.

Thank you in advance for any insights or assistance you can offer!

@Atlas_Amazon

@Emet_Amazon

46 görüntüleme
9 yanıt
Etiketler:Devre dışı bırakıldı, Satıcı performansı, Satış Ortağı Destek Ekibi
00
Yanıtla
user profile
Seller_ZprJMm7kiEhKS

510(k) premarket notification not recognized by amazon

Hi! We're reaching out to the community hoping someone can offer some guidance on a frustrating issue we're encountering.

Our listing was recently deactivated by Amazon, citing it as a professional-use only medical device that requires a valid 510(k) premarket notification.

Case ID: 17494248771

We have submitted the following documentation to Amazon for review:

✅ The relevant FDA 510(k) number

✅ Clear photographs of all sides of the product packaging

✅ Photographs of the complete instructions for use

✅ Our FDA Establishment Registration Number

✅ Letter from the manufacturer

✅ Confirmation that the device name matches exactly as it is listed on the FDA database

Despite providing all of this information, we continue to receive the same generic response from Amazon stating:

"The FDA 510(k) provided does not cover this product. Sellers are expected to provide complete and accurate information in order for us to proceed with our review of this request."

We have meticulously reviewed the FDA database and are certain that the 510(k) number we provided is indeed the correct one for our product. We are feeling stuck and unsure of what additional information Amazon might be looking for or what we might be missing.

Has anyone else experienced a similar situation with a 510(k) review and the recurring canned responses? Any advice on how to break this cycle, specific contacts within Amazon to reach out to, or potential escalation steps we could take would be incredibly helpful.

Thank you in advance for any insights or assistance you can offer!

@Atlas_Amazon

@Emet_Amazon

Etiketler:Devre dışı bırakıldı, Satıcı performansı, Satış Ortağı Destek Ekibi
00
46 görüntüleme
9 yanıt
Yanıtla
9 yanıt
user profile
Atlas_Amazon

Hello @Seller_ZprJMm7kiEhKS

Thank you for the information provided regarding the recent issues you have experienced with your listing being pulled down. I know this can be increasingly frustrating given you have the provided the details regarding the 510(k) number for the product, so I do want to get you assistance.

user profile
Seller_ZprJMm7kiEhKS

Case ID: 17494248771

Gönderiyi görüntüle

I went ahead and did review the case information you shared, and did see where our team responded regarding the discrepancy in the information you provided and what is available to them. From the details you shared, I see where the information does appear to align, so I did go ahead and transfer your details off to be further reviewed.

At this time, I will not have any updates regarding the situation, but I will continue to monitor and will refer back to this thread once there are details available to be shared.

Best,

Atlas

00
user profile
Atlas_Amazon

Hello @Seller_ZprJMm7kiEhKS

user profile
Atlas_Amazon
I wanted to check in on your situation as our team did provide an update that they are actively reviewing the situation with the second listing.
Gönderiyi görüntüle

I wanted to follow up as I have heard back from our teams regarding the additional ASIN you had experienced issues with. They have gone ahead and taken action to remove the restrictions on the listing, so I would encourage you to review to determine if you are still seeing a concern. If you are, please provide a screenshot that includes a date and time stamp so I may continue to work with our teams to get you support.

If everything does appear as resolved, no additional action will be required from you. However, I will encourage you to refer to the forums for any future questions or concerns that you might have.

Best,

Atlas

00
Yeni etkinlikler hakkında bildirim almak için bu tartışmayı takip edin
user profile
Seller_ZprJMm7kiEhKS

510(k) premarket notification not recognized by amazon

Hi! We're reaching out to the community hoping someone can offer some guidance on a frustrating issue we're encountering.

Our listing was recently deactivated by Amazon, citing it as a professional-use only medical device that requires a valid 510(k) premarket notification.

Case ID: 17494248771

We have submitted the following documentation to Amazon for review:

✅ The relevant FDA 510(k) number

✅ Clear photographs of all sides of the product packaging

✅ Photographs of the complete instructions for use

✅ Our FDA Establishment Registration Number

✅ Letter from the manufacturer

✅ Confirmation that the device name matches exactly as it is listed on the FDA database

Despite providing all of this information, we continue to receive the same generic response from Amazon stating:

"The FDA 510(k) provided does not cover this product. Sellers are expected to provide complete and accurate information in order for us to proceed with our review of this request."

We have meticulously reviewed the FDA database and are certain that the 510(k) number we provided is indeed the correct one for our product. We are feeling stuck and unsure of what additional information Amazon might be looking for or what we might be missing.

Has anyone else experienced a similar situation with a 510(k) review and the recurring canned responses? Any advice on how to break this cycle, specific contacts within Amazon to reach out to, or potential escalation steps we could take would be incredibly helpful.

Thank you in advance for any insights or assistance you can offer!

@Atlas_Amazon

@Emet_Amazon

46 görüntüleme
9 yanıt
Etiketler:Devre dışı bırakıldı, Satıcı performansı, Satış Ortağı Destek Ekibi
00
Yanıtla
user profile
Seller_ZprJMm7kiEhKS

510(k) premarket notification not recognized by amazon

Hi! We're reaching out to the community hoping someone can offer some guidance on a frustrating issue we're encountering.

Our listing was recently deactivated by Amazon, citing it as a professional-use only medical device that requires a valid 510(k) premarket notification.

Case ID: 17494248771

We have submitted the following documentation to Amazon for review:

✅ The relevant FDA 510(k) number

✅ Clear photographs of all sides of the product packaging

✅ Photographs of the complete instructions for use

✅ Our FDA Establishment Registration Number

✅ Letter from the manufacturer

✅ Confirmation that the device name matches exactly as it is listed on the FDA database

Despite providing all of this information, we continue to receive the same generic response from Amazon stating:

"The FDA 510(k) provided does not cover this product. Sellers are expected to provide complete and accurate information in order for us to proceed with our review of this request."

We have meticulously reviewed the FDA database and are certain that the 510(k) number we provided is indeed the correct one for our product. We are feeling stuck and unsure of what additional information Amazon might be looking for or what we might be missing.

Has anyone else experienced a similar situation with a 510(k) review and the recurring canned responses? Any advice on how to break this cycle, specific contacts within Amazon to reach out to, or potential escalation steps we could take would be incredibly helpful.

Thank you in advance for any insights or assistance you can offer!

@Atlas_Amazon

@Emet_Amazon

Etiketler:Devre dışı bırakıldı, Satıcı performansı, Satış Ortağı Destek Ekibi
00
46 görüntüleme
9 yanıt
Yanıtla
user profile

510(k) premarket notification not recognized by amazon

Seller_ZprJMm7kiEhKS tarafından yazıldı

Hi! We're reaching out to the community hoping someone can offer some guidance on a frustrating issue we're encountering.

Our listing was recently deactivated by Amazon, citing it as a professional-use only medical device that requires a valid 510(k) premarket notification.

Case ID: 17494248771

We have submitted the following documentation to Amazon for review:

✅ The relevant FDA 510(k) number

✅ Clear photographs of all sides of the product packaging

✅ Photographs of the complete instructions for use

✅ Our FDA Establishment Registration Number

✅ Letter from the manufacturer

✅ Confirmation that the device name matches exactly as it is listed on the FDA database

Despite providing all of this information, we continue to receive the same generic response from Amazon stating:

"The FDA 510(k) provided does not cover this product. Sellers are expected to provide complete and accurate information in order for us to proceed with our review of this request."

We have meticulously reviewed the FDA database and are certain that the 510(k) number we provided is indeed the correct one for our product. We are feeling stuck and unsure of what additional information Amazon might be looking for or what we might be missing.

Has anyone else experienced a similar situation with a 510(k) review and the recurring canned responses? Any advice on how to break this cycle, specific contacts within Amazon to reach out to, or potential escalation steps we could take would be incredibly helpful.

Thank you in advance for any insights or assistance you can offer!

@Atlas_Amazon

@Emet_Amazon

Etiketler:Devre dışı bırakıldı, Satıcı performansı, Satış Ortağı Destek Ekibi
00
46 görüntüleme
9 yanıt
Yanıtla
9 yanıt
9 yanıt
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user profile
Atlas_Amazon

Hello @Seller_ZprJMm7kiEhKS

Thank you for the information provided regarding the recent issues you have experienced with your listing being pulled down. I know this can be increasingly frustrating given you have the provided the details regarding the 510(k) number for the product, so I do want to get you assistance.

user profile
Seller_ZprJMm7kiEhKS

Case ID: 17494248771

Gönderiyi görüntüle

I went ahead and did review the case information you shared, and did see where our team responded regarding the discrepancy in the information you provided and what is available to them. From the details you shared, I see where the information does appear to align, so I did go ahead and transfer your details off to be further reviewed.

At this time, I will not have any updates regarding the situation, but I will continue to monitor and will refer back to this thread once there are details available to be shared.

Best,

Atlas

00
user profile
Atlas_Amazon

Hello @Seller_ZprJMm7kiEhKS

user profile
Atlas_Amazon
I wanted to check in on your situation as our team did provide an update that they are actively reviewing the situation with the second listing.
Gönderiyi görüntüle

I wanted to follow up as I have heard back from our teams regarding the additional ASIN you had experienced issues with. They have gone ahead and taken action to remove the restrictions on the listing, so I would encourage you to review to determine if you are still seeing a concern. If you are, please provide a screenshot that includes a date and time stamp so I may continue to work with our teams to get you support.

If everything does appear as resolved, no additional action will be required from you. However, I will encourage you to refer to the forums for any future questions or concerns that you might have.

Best,

Atlas

00
Yeni etkinlikler hakkında bildirim almak için bu tartışmayı takip edin
user profile
Atlas_Amazon

Hello @Seller_ZprJMm7kiEhKS

Thank you for the information provided regarding the recent issues you have experienced with your listing being pulled down. I know this can be increasingly frustrating given you have the provided the details regarding the 510(k) number for the product, so I do want to get you assistance.

user profile
Seller_ZprJMm7kiEhKS

Case ID: 17494248771

Gönderiyi görüntüle

I went ahead and did review the case information you shared, and did see where our team responded regarding the discrepancy in the information you provided and what is available to them. From the details you shared, I see where the information does appear to align, so I did go ahead and transfer your details off to be further reviewed.

At this time, I will not have any updates regarding the situation, but I will continue to monitor and will refer back to this thread once there are details available to be shared.

Best,

Atlas

00
user profile
Atlas_Amazon

Hello @Seller_ZprJMm7kiEhKS

Thank you for the information provided regarding the recent issues you have experienced with your listing being pulled down. I know this can be increasingly frustrating given you have the provided the details regarding the 510(k) number for the product, so I do want to get you assistance.

user profile
Seller_ZprJMm7kiEhKS

Case ID: 17494248771

Gönderiyi görüntüle

I went ahead and did review the case information you shared, and did see where our team responded regarding the discrepancy in the information you provided and what is available to them. From the details you shared, I see where the information does appear to align, so I did go ahead and transfer your details off to be further reviewed.

At this time, I will not have any updates regarding the situation, but I will continue to monitor and will refer back to this thread once there are details available to be shared.

Best,

Atlas

00
Yanıtla
user profile
Atlas_Amazon

Hello @Seller_ZprJMm7kiEhKS

user profile
Atlas_Amazon
I wanted to check in on your situation as our team did provide an update that they are actively reviewing the situation with the second listing.
Gönderiyi görüntüle

I wanted to follow up as I have heard back from our teams regarding the additional ASIN you had experienced issues with. They have gone ahead and taken action to remove the restrictions on the listing, so I would encourage you to review to determine if you are still seeing a concern. If you are, please provide a screenshot that includes a date and time stamp so I may continue to work with our teams to get you support.

If everything does appear as resolved, no additional action will be required from you. However, I will encourage you to refer to the forums for any future questions or concerns that you might have.

Best,

Atlas

00
user profile
Atlas_Amazon

Hello @Seller_ZprJMm7kiEhKS

user profile
Atlas_Amazon
I wanted to check in on your situation as our team did provide an update that they are actively reviewing the situation with the second listing.
Gönderiyi görüntüle

I wanted to follow up as I have heard back from our teams regarding the additional ASIN you had experienced issues with. They have gone ahead and taken action to remove the restrictions on the listing, so I would encourage you to review to determine if you are still seeing a concern. If you are, please provide a screenshot that includes a date and time stamp so I may continue to work with our teams to get you support.

If everything does appear as resolved, no additional action will be required from you. However, I will encourage you to refer to the forums for any future questions or concerns that you might have.

Best,

Atlas

00
Yanıtla
Yeni etkinlikler hakkında bildirim almak için bu tartışmayı takip edin