Hello,
We are having trouble with our far infrared product being classified as a medical device. We have appealed multiple times and provided Amazon’s required exemption evidence, but they still require us to provide a 510(k) number
The deactivation reason is: 1. The product is identified as a high-frequency laser, LED, or other light therapy device for the treatment of acne, which is considered a medical device for professional use only.
2. They believe that the exemption evidence we provided does not include our product
I tried to ask customer service to help me look up the link trigger words, but nothing worked, and they said they didn’t know either. Now I have deleted the medical words I think may be in the description, but it still doesn’t work. Here is the information I have provided:
1. The FDA registration number of the device, showing that the product is classified as a 510k exempt device.
2. Provide pictures of the box and product manual
3. Confirmation letter from the manufacturer that the device is registered with the FDA as a Class I, 510k exempt device
Despite providing all this information, I received a response from Amazon, again requiring 510k clearance. I don't know how to further clarify that this is an exempt device, it is officially registered and does not require 510k clearance.
Here is our case ID: 16655505691
Requesting some pointers from experienced sellers. Can you guys help me with this? Many thanks
Thanks in advance,
Hi there @Seller_vdDccDlU5gw1e,
Thank you for reaching out with your concerns with your product. I've reviewed your case and at this time it appears that the the ASIN was restored and is no longer classified as a medical device. If you are still having issues with this ASIN will you please let me know. Thank you for your understanding.
-Glenn
Hello, thank you for your reply. I have another ASIN of the same product that is undergoing the same review. Please help me. Thank you. Case ID: 16858348571
Can you help me get through this issue? I am having the exact same issue. What did you ask your supplier for so that you can obtain the letters you mentioned? I am desperately trying to get through this. Any help is appreciated.