Help Needed: ASIN B0DCNM4HQ3 - Medical Device 510(K) Issue
I'm currently seeking guidance regarding the delisting of our product with Amazon Standard Identification Number (ASIN) B0DCNM4HQ3, which has been determined to be a medical device.
This is a neck massager designed to relax the neck muscles through vibration and will not produce any form of alteration or therapeutic effect.
However, the product was suddenly delisted during the sales process, and we were informed that we need to submit a 510(K) or a 510(K) exemption certificate.
The text of the notice is as follows: "Hello, We received your appeal for the ASINs B0DCNM4HQ3, but we are unable to reactivate your ASINs at this time. What actions do I need to take? To reactivate your ASINs, send the following documentation and information: -- The 510(k) number issued by the United States Food and Drug Administration (FDA) for this product. Additionally, 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), then also provide the following: -- The device name as it appears in the manufacturer’s device listing. -- A valid purchase order, invoice, or letter, all must be written in English, from the manufacturer confirming that the device was purchased from the manufacturer. If the product does not require a 510(k), provide an explanation along with proof to support the 510(K) claim exemption."
In case ID: 16535005791, we have submitted our FDA certificate multiple times, along with screenshots of the exemption from the official FDA website to prove that our product code is ISA and it falls under the 510(K) exemption category.
At the same time, we have also provided evidence such as six-view pictures of the product packaging, the instruction manual, and the purchase certificate.
After we submitted the relevant content multiple times, the problem still hasn't been solved.
Hello, @Glenn_Amazon. I've noticed that you have assisted in handling similar cases before. Could you please provide me with some guidance?
Thank you in advance.
Help Needed: ASIN B0DCNM4HQ3 - Medical Device 510(K) Issue
I'm currently seeking guidance regarding the delisting of our product with Amazon Standard Identification Number (ASIN) B0DCNM4HQ3, which has been determined to be a medical device.
This is a neck massager designed to relax the neck muscles through vibration and will not produce any form of alteration or therapeutic effect.
However, the product was suddenly delisted during the sales process, and we were informed that we need to submit a 510(K) or a 510(K) exemption certificate.
The text of the notice is as follows: "Hello, We received your appeal for the ASINs B0DCNM4HQ3, but we are unable to reactivate your ASINs at this time. What actions do I need to take? To reactivate your ASINs, send the following documentation and information: -- The 510(k) number issued by the United States Food and Drug Administration (FDA) for this product. Additionally, 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), then also provide the following: -- The device name as it appears in the manufacturer’s device listing. -- A valid purchase order, invoice, or letter, all must be written in English, from the manufacturer confirming that the device was purchased from the manufacturer. If the product does not require a 510(k), provide an explanation along with proof to support the 510(K) claim exemption."
In case ID: 16535005791, we have submitted our FDA certificate multiple times, along with screenshots of the exemption from the official FDA website to prove that our product code is ISA and it falls under the 510(K) exemption category.
At the same time, we have also provided evidence such as six-view pictures of the product packaging, the instruction manual, and the purchase certificate.
After we submitted the relevant content multiple times, the problem still hasn't been solved.
Hello, @Glenn_Amazon. I've noticed that you have assisted in handling similar cases before. Could you please provide me with some guidance?
Thank you in advance.
0 yanıt
Michelle_Amazon
Hello @Seller_Ty07SuFh1FkgF,
Thanks for reaching out. I have reviewed your case, which has been reviewed by our legal team. They have stated: This particular product is a EMS device and it necessitates a pre-market approval number 510(k) to be listed for sale on Amazon.
You will need to appeal with the proper 510(k) document in order for the product to be reviewed again for possible reinstatement.
Please appeal with the required information and let me know if you need help once you appeal with the new information and the case is greater than 14 days old.
Regards,
Michelle
