Amazon identify my listing as a medical device and got restricted product policy violation inactive my listing and asked for 510k number and product details etc as my product doesn't need 510k or FDA approval certificate

Hi everyone.
@Kika


Amazon identified my listing as a medical device and restricted it due to a product policy violation, making it inactive. They have asked for a 510(k) number, product details, and other information. However, my product does not require 510(k) clearance or FDA approval.It shows that I can appeal. Before submitting the appeal, what should I keep in mind if I don’t have a 510(k) number, and what should I upload? I’m also looking for someone who has already resolved a similar issue.Thank you.

Hello @Hk123,

thank you for joining the forum! I am sorry to hear that Amazon deactivated your listing due to a restricted policy violation.

Unfortunately, these are very common. They are usually triggered once a specific keyword is detected by bots within the listing, which relates to a category of prohibited / restricted products.

What matters is whether your product in fact is a medical device or not. If it indeed is, then you won’t be able to sell it unless you supply everything requested.

Could you provide more information about what kind of product this is?

Hello @Kika .
Thank you for your response.
Could i share my product details in inbox?
I tried to inbox you… but sorry i m new to this form and didn’t find the mag option.
Looking forward
Thank you

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@Kika still looking for your response.
I want to discuss it in details.

Looking forward
Thank you

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Yes, I could enable the private messages for you. These are disabled by default, because there are many spamming accounts joining.

However, feel free to post info about the product here. This is a safe space and no one is going to attack your listing.