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