Our product had been mistakenly identified as a professional-use only medical device. And as per the performance notification, it required us to provide the following information to appeal: (1) photos of all sides of the product packaging, (2) photos of the instructions for use included with the product, and (3) the 510(k) number issued by the U.S. Food & Drug Administration (FDA) for this product. 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), please also provide, with the information noted above, (1) the device manufacturer’s FDA establishment registration number OR owner/operator number, (2) the device name as it appears in the manufacturer’s device listing, and (3) a purchase order, invoice OR letter (written in English) from the manufacturer confirming that the device was purchased from the manufacturer.

We provided all these above information and documents to appeal. However, we got their reply that: Attached invoice is not authorized / valid. They required us to provide "A scanned copy of authorized purchase order, invoice OR letter (written in English) from the manufacturer confirming that the device was purchased from the manufacturer. The document should be image of the original document with the manufacturer's signature/seal stamp and valid invoice number.".

There is contradictory for this request. As it required the invoice with the manufacturer's signature/seal stamp and valid invoice number, then it can only to be Chinese invocie. However, it also requires the invoice to be written in English.

If okay, could you help provide a sample of the invoice regarding the review of Restricted Product of a professional-use only medical device?

Highly appreciate for your generous help!