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Seller_IpX1WmvzBSp6S

Medical device

Hello,

My listing got removed due to violation of amazon policy.

My product is an anti snoring device, not signed as a medical device, but still not possible to reactivate the listing, and no-one is giving me an explanation, no matter how many cases I open.

If i do not list it in the category of medical devices, I do not need a FDA certificate, right?

How can I go on, been in this situation since 22 days?

Thank you

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Seller_IpX1WmvzBSp6S

Medical device

Hello,

My listing got removed due to violation of amazon policy.

My product is an anti snoring device, not signed as a medical device, but still not possible to reactivate the listing, and no-one is giving me an explanation, no matter how many cases I open.

If i do not list it in the category of medical devices, I do not need a FDA certificate, right?

How can I go on, been in this situation since 22 days?

Thank you

Tags:Restricted Products
00
23 views
1 reply
Reply
0 replies
user profile
Michelle_Amazon

Hi @Seller_IpX1WmvzBSp6S,

Thanks for reaching out. If you item is to prevent snoring it's treating a condition, so even if it's not listed under medical devices, it could be considered a medical device and require the testing that is needed for medical devices as listed in our help page. Once you review this information and confirm that you have all the required testing, please provide me with your case ID so I can ask for it to be expedited. If you do not have the required testing, I would advise you close your case until you have the proper documentation, then appeal again as your current appeal will be denied without it.

As noted in your account:

This product has been identified as an intra-oral device used to treat snoring and or sleep apnea, which is a professional-use only medical device. Per Amazon policy, professional-use only medical devices may only be sold to appropriately licensed healthcare customers who have Amazon Business accounts. If you believe this determination was made in error and your product is not a professional-use only medical device, please contact Seller or Vendor Support and provide (1) photos of all sides of the product packaging, (2) photos of the instructions for use included with the product, and (3) the 510(k) number issued by the U.S. Food & Drug Administration (FDA) for this product. If the name of the product provided on the product packaging, instructions for use, or ASIN detail page does not match the device name provided on the 510(k), please also provide, with the information noted above, (1) the device manufacturer’s FDA establishment registration number OR owner/operator number, (2) the device name as it appears in the manufacturer’s device listing, and (3) a purchase order, invoice OR letter (written in English) from the manufacturer confirming that the device was purchased from the manufacturer. For more information, please see our Medical Devices and Accessories Help Page and the following FDA guidance.

I hope this is helpful!

Michelle

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Seller_IpX1WmvzBSp6S

Medical device

Hello,

My listing got removed due to violation of amazon policy.

My product is an anti snoring device, not signed as a medical device, but still not possible to reactivate the listing, and no-one is giving me an explanation, no matter how many cases I open.

If i do not list it in the category of medical devices, I do not need a FDA certificate, right?

How can I go on, been in this situation since 22 days?

Thank you

23 views
1 reply
Tags:Restricted Products
00
Reply
user profile
Seller_IpX1WmvzBSp6S

Medical device

Hello,

My listing got removed due to violation of amazon policy.

My product is an anti snoring device, not signed as a medical device, but still not possible to reactivate the listing, and no-one is giving me an explanation, no matter how many cases I open.

If i do not list it in the category of medical devices, I do not need a FDA certificate, right?

How can I go on, been in this situation since 22 days?

Thank you

Tags:Restricted Products
00
23 views
1 reply
Reply
user profile

Medical device

by Seller_IpX1WmvzBSp6S

Hello,

My listing got removed due to violation of amazon policy.

My product is an anti snoring device, not signed as a medical device, but still not possible to reactivate the listing, and no-one is giving me an explanation, no matter how many cases I open.

If i do not list it in the category of medical devices, I do not need a FDA certificate, right?

How can I go on, been in this situation since 22 days?

Thank you

Tags:Restricted Products
00
23 views
1 reply
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Michelle_Amazon

Hi @Seller_IpX1WmvzBSp6S,

Thanks for reaching out. If you item is to prevent snoring it's treating a condition, so even if it's not listed under medical devices, it could be considered a medical device and require the testing that is needed for medical devices as listed in our help page. Once you review this information and confirm that you have all the required testing, please provide me with your case ID so I can ask for it to be expedited. If you do not have the required testing, I would advise you close your case until you have the proper documentation, then appeal again as your current appeal will be denied without it.

As noted in your account:

This product has been identified as an intra-oral device used to treat snoring and or sleep apnea, which is a professional-use only medical device. Per Amazon policy, professional-use only medical devices may only be sold to appropriately licensed healthcare customers who have Amazon Business accounts. If you believe this determination was made in error and your product is not a professional-use only medical device, please contact Seller or Vendor Support and provide (1) photos of all sides of the product packaging, (2) photos of the instructions for use included with the product, and (3) the 510(k) number issued by the U.S. Food & Drug Administration (FDA) for this product. If the name of the product provided on the product packaging, instructions for use, or ASIN detail page does not match the device name provided on the 510(k), please also provide, with the information noted above, (1) the device manufacturer’s FDA establishment registration number OR owner/operator number, (2) the device name as it appears in the manufacturer’s device listing, and (3) a purchase order, invoice OR letter (written in English) from the manufacturer confirming that the device was purchased from the manufacturer. For more information, please see our Medical Devices and Accessories Help Page and the following FDA guidance.

I hope this is helpful!

Michelle

00
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user profile
Michelle_Amazon

Hi @Seller_IpX1WmvzBSp6S,

Thanks for reaching out. If you item is to prevent snoring it's treating a condition, so even if it's not listed under medical devices, it could be considered a medical device and require the testing that is needed for medical devices as listed in our help page. Once you review this information and confirm that you have all the required testing, please provide me with your case ID so I can ask for it to be expedited. If you do not have the required testing, I would advise you close your case until you have the proper documentation, then appeal again as your current appeal will be denied without it.

As noted in your account:

This product has been identified as an intra-oral device used to treat snoring and or sleep apnea, which is a professional-use only medical device. Per Amazon policy, professional-use only medical devices may only be sold to appropriately licensed healthcare customers who have Amazon Business accounts. If you believe this determination was made in error and your product is not a professional-use only medical device, please contact Seller or Vendor Support and provide (1) photos of all sides of the product packaging, (2) photos of the instructions for use included with the product, and (3) the 510(k) number issued by the U.S. Food & Drug Administration (FDA) for this product. If the name of the product provided on the product packaging, instructions for use, or ASIN detail page does not match the device name provided on the 510(k), please also provide, with the information noted above, (1) the device manufacturer’s FDA establishment registration number OR owner/operator number, (2) the device name as it appears in the manufacturer’s device listing, and (3) a purchase order, invoice OR letter (written in English) from the manufacturer confirming that the device was purchased from the manufacturer. For more information, please see our Medical Devices and Accessories Help Page and the following FDA guidance.

I hope this is helpful!

Michelle

00
user profile
Michelle_Amazon

Hi @Seller_IpX1WmvzBSp6S,

Thanks for reaching out. If you item is to prevent snoring it's treating a condition, so even if it's not listed under medical devices, it could be considered a medical device and require the testing that is needed for medical devices as listed in our help page. Once you review this information and confirm that you have all the required testing, please provide me with your case ID so I can ask for it to be expedited. If you do not have the required testing, I would advise you close your case until you have the proper documentation, then appeal again as your current appeal will be denied without it.

As noted in your account:

This product has been identified as an intra-oral device used to treat snoring and or sleep apnea, which is a professional-use only medical device. Per Amazon policy, professional-use only medical devices may only be sold to appropriately licensed healthcare customers who have Amazon Business accounts. If you believe this determination was made in error and your product is not a professional-use only medical device, please contact Seller or Vendor Support and provide (1) photos of all sides of the product packaging, (2) photos of the instructions for use included with the product, and (3) the 510(k) number issued by the U.S. Food & Drug Administration (FDA) for this product. If the name of the product provided on the product packaging, instructions for use, or ASIN detail page does not match the device name provided on the 510(k), please also provide, with the information noted above, (1) the device manufacturer’s FDA establishment registration number OR owner/operator number, (2) the device name as it appears in the manufacturer’s device listing, and (3) a purchase order, invoice OR letter (written in English) from the manufacturer confirming that the device was purchased from the manufacturer. For more information, please see our Medical Devices and Accessories Help Page and the following FDA guidance.

I hope this is helpful!

Michelle

00
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