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Seller_WsgxkJhoqWLWB

The 510(k) number

Hi,

We have recently Listed our 1 product on amazon.com. our product has been flagged as a medical device needing The 510(k) number issued by the United States Food and Drug Administration (FDA) for this product

This really isn't the case with our product; there are around 600 pages of other sellers selling the same product.

Amazon has said that If the product does not require a 510(k), provide an explanation along with proof to support the 510(K) claim exemption.

My question is where and how do we get a 510K for our product or how to provide an explanation with proof to support the 510(k) claim exemption?

Any advice and help would be greatly appreciated.

Thanks

165 visualizações
11 respostas
Criar e gerenciar ofertas
Tags:Adicionar um produto, Oferta desativada, Ofertas, Produtos restritos, Remoção de produto
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Seller_WsgxkJhoqWLWB

The 510(k) number

Hi,

We have recently Listed our 1 product on amazon.com. our product has been flagged as a medical device needing The 510(k) number issued by the United States Food and Drug Administration (FDA) for this product

This really isn't the case with our product; there are around 600 pages of other sellers selling the same product.

Amazon has said that If the product does not require a 510(k), provide an explanation along with proof to support the 510(K) claim exemption.

My question is where and how do we get a 510K for our product or how to provide an explanation with proof to support the 510(k) claim exemption?

Any advice and help would be greatly appreciated.

Thanks

Criar e gerenciar ofertas
Tags:Adicionar um produto, Oferta desativada, Ofertas, Produtos restritos, Remoção de produto
10
165 visualizações
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Danny_Amazon
Em resposta à postagem de: Seller_WsgxkJhoqWLWB
Resposta mais útil

Hello @Seller_WsgxkJhoqWLWB- thank you for these details. While I can't speak to the situations of other sellers on the platform, I did want to let you know I have contacted our escalation team requesting their review and assistance on this issue. They may reach out to you through a new case ID, but I'll be sure to share any updates I receive on this thread.

Regarding the pictures, it may be beneficial to call out in the email that the instructions for use are located on the product's packaging to help avoid confusion.

Thanks,

Danny

00
0 resposta
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Danny_Amazon
Em resposta à postagem de: Seller_WsgxkJhoqWLWB

Hey there @Seller_WsgxkJhoqWLWB- thanks for sharing this question to forums! While other sellers chime in with their experience with this piece of documentation, I wanted to provide the relevant help page on medical devices, which require the 501k.

While I can't speak to other sellers, I am wondering if your product is categorized the same as the others on the website? It may be worthwhile to explore the possibility of shifting the category away from medical devices if that truly is not the best fit for the item.

Let me know if this helps, or if you've found a different approach in the past couple days since posting.

Thanks!

Danny

00
Siga esta discussão para ser notificado sobre novas atividades.
user profile
Seller_WsgxkJhoqWLWB

The 510(k) number

Hi,

We have recently Listed our 1 product on amazon.com. our product has been flagged as a medical device needing The 510(k) number issued by the United States Food and Drug Administration (FDA) for this product

This really isn't the case with our product; there are around 600 pages of other sellers selling the same product.

Amazon has said that If the product does not require a 510(k), provide an explanation along with proof to support the 510(K) claim exemption.

My question is where and how do we get a 510K for our product or how to provide an explanation with proof to support the 510(k) claim exemption?

Any advice and help would be greatly appreciated.

Thanks

165 visualizações
11 respostas
Criar e gerenciar ofertas
Tags:Adicionar um produto, Oferta desativada, Ofertas, Produtos restritos, Remoção de produto
10
Responder
user profile
Seller_WsgxkJhoqWLWB

The 510(k) number

Hi,

We have recently Listed our 1 product on amazon.com. our product has been flagged as a medical device needing The 510(k) number issued by the United States Food and Drug Administration (FDA) for this product

This really isn't the case with our product; there are around 600 pages of other sellers selling the same product.

Amazon has said that If the product does not require a 510(k), provide an explanation along with proof to support the 510(K) claim exemption.

My question is where and how do we get a 510K for our product or how to provide an explanation with proof to support the 510(k) claim exemption?

Any advice and help would be greatly appreciated.

Thanks

Criar e gerenciar ofertas
Tags:Adicionar um produto, Oferta desativada, Ofertas, Produtos restritos, Remoção de produto
10
165 visualizações
11 respostas
Responder
user profile

The 510(k) number

de Seller_WsgxkJhoqWLWB

Hi,

We have recently Listed our 1 product on amazon.com. our product has been flagged as a medical device needing The 510(k) number issued by the United States Food and Drug Administration (FDA) for this product

This really isn't the case with our product; there are around 600 pages of other sellers selling the same product.

Amazon has said that If the product does not require a 510(k), provide an explanation along with proof to support the 510(K) claim exemption.

My question is where and how do we get a 510K for our product or how to provide an explanation with proof to support the 510(k) claim exemption?

Any advice and help would be greatly appreciated.

Thanks

Criar e gerenciar ofertas
Tags:Adicionar um produto, Oferta desativada, Ofertas, Produtos restritos, Remoção de produto
10
165 visualizações
11 respostas
Responder
user profile
Danny_Amazon
Em resposta à postagem de: Seller_WsgxkJhoqWLWB
Resposta mais útil

Hello @Seller_WsgxkJhoqWLWB- thank you for these details. While I can't speak to the situations of other sellers on the platform, I did want to let you know I have contacted our escalation team requesting their review and assistance on this issue. They may reach out to you through a new case ID, but I'll be sure to share any updates I receive on this thread.

Regarding the pictures, it may be beneficial to call out in the email that the instructions for use are located on the product's packaging to help avoid confusion.

Thanks,

Danny

00
user profile
Danny_Amazon
Em resposta à postagem de: Seller_WsgxkJhoqWLWB
Resposta mais útil

Hello @Seller_WsgxkJhoqWLWB- thank you for these details. While I can't speak to the situations of other sellers on the platform, I did want to let you know I have contacted our escalation team requesting their review and assistance on this issue. They may reach out to you through a new case ID, but I'll be sure to share any updates I receive on this thread.

Regarding the pictures, it may be beneficial to call out in the email that the instructions for use are located on the product's packaging to help avoid confusion.

Thanks,

Danny

00
user profile
Danny_Amazon
Em resposta à postagem de: Seller_WsgxkJhoqWLWB
Resposta mais útil

Hello @Seller_WsgxkJhoqWLWB- thank you for these details. While I can't speak to the situations of other sellers on the platform, I did want to let you know I have contacted our escalation team requesting their review and assistance on this issue. They may reach out to you through a new case ID, but I'll be sure to share any updates I receive on this thread.

Regarding the pictures, it may be beneficial to call out in the email that the instructions for use are located on the product's packaging to help avoid confusion.

Thanks,

Danny

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Danny_Amazon
Em resposta à postagem de: Seller_WsgxkJhoqWLWB

Hey there @Seller_WsgxkJhoqWLWB- thanks for sharing this question to forums! While other sellers chime in with their experience with this piece of documentation, I wanted to provide the relevant help page on medical devices, which require the 501k.

While I can't speak to other sellers, I am wondering if your product is categorized the same as the others on the website? It may be worthwhile to explore the possibility of shifting the category away from medical devices if that truly is not the best fit for the item.

Let me know if this helps, or if you've found a different approach in the past couple days since posting.

Thanks!

Danny

00
Siga esta discussão para ser notificado sobre novas atividades.
user profile
Danny_Amazon
Em resposta à postagem de: Seller_WsgxkJhoqWLWB

Hey there @Seller_WsgxkJhoqWLWB- thanks for sharing this question to forums! While other sellers chime in with their experience with this piece of documentation, I wanted to provide the relevant help page on medical devices, which require the 501k.

While I can't speak to other sellers, I am wondering if your product is categorized the same as the others on the website? It may be worthwhile to explore the possibility of shifting the category away from medical devices if that truly is not the best fit for the item.

Let me know if this helps, or if you've found a different approach in the past couple days since posting.

Thanks!

Danny

00
user profile
Danny_Amazon
Em resposta à postagem de: Seller_WsgxkJhoqWLWB

Hey there @Seller_WsgxkJhoqWLWB- thanks for sharing this question to forums! While other sellers chime in with their experience with this piece of documentation, I wanted to provide the relevant help page on medical devices, which require the 501k.

While I can't speak to other sellers, I am wondering if your product is categorized the same as the others on the website? It may be worthwhile to explore the possibility of shifting the category away from medical devices if that truly is not the best fit for the item.

Let me know if this helps, or if you've found a different approach in the past couple days since posting.

Thanks!

Danny

00
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