misclassification deemed a medical device for professional use
Hello Amazon Team,
I am writing to express my confusion regarding the misclassification of my company’s product as a spirometer, which is deemed a medical device for professional use. Promptly after the misclassification, I submitted the necessary documentation to verify that our product is a Class I exempt device and does not require a FDA510(k) number. Unfortunately, I have been met with automated responses consistently requesting the 510(k) number, and I am at a loss as to how to proceed.
I kindly request your assistance in resolving this matter, as it is essential for our product to be correctly categorized. Your prompt attention to this issue would be greatly appreciated.
CASEID 15503626121
Thank you for your time and understanding.
Seller_CW0P5hgbsiqWX
It doesn't matter. The ruling is not going to change.
While you look at the product one way, this is how Amazon looks at the product when making the decision.
Amazon views the product as the potential buyer MAY perceive it as a professional medical devise. Thus, to prevents any legal issues, your sale of the item is blocked.
To unblock the product, get a COC from Underwriters Laboratories, showing the item meeds all medical grads standards. Amazon will then accept your item for sale on the site.
