How could a watch be an electrocardiograph machine?
ASIN: B01HS4VHIY
Title: Wego Heart Rate Monitor. It is simply a watch, monitors user's heart rate.
This product has been identified as an electrocardiograph machines or related device, which is a professional-use only medical device. These are Class II medical devices and are required to be licensed with Health Canada in order to be sold in Canada.
I have submitted an appeal with plenty of photos and user manual of this product clearly stating "It is not a medical device" on its box and in it's user manual. I did not receive any explanation about my appeal. Has is been accepted or not?
Unfortunately, It is still sitting my restricted product violation.
What triggers such violations and how appeals are being evaluated?
Has my appeal been read by a human or is it all AI nowadays?
Thanks
How could a watch be an electrocardiograph machine?
ASIN: B01HS4VHIY
Title: Wego Heart Rate Monitor. It is simply a watch, monitors user's heart rate.
This product has been identified as an electrocardiograph machines or related device, which is a professional-use only medical device. These are Class II medical devices and are required to be licensed with Health Canada in order to be sold in Canada.
I have submitted an appeal with plenty of photos and user manual of this product clearly stating "It is not a medical device" on its box and in it's user manual. I did not receive any explanation about my appeal. Has is been accepted or not?
Unfortunately, It is still sitting my restricted product violation.
What triggers such violations and how appeals are being evaluated?
Has my appeal been read by a human or is it all AI nowadays?
Thanks
7 replies
Emet_Amazon
Hello @Seller_jkytlOaIXFuqf,
Thank you for posting your concerns with a restricted product policy violation.
ASIN: B01HS4VHIY
Title: Wego Heart Rate Monitor. It is simply a watch, monitors user's heart rate.
This product has been identified as an electrocardiograph machines or related device, which is a professional-use only medical device. These are Class II medical devices and are required to be licensed with Health Canada in order to be sold in Canada.
I have submitted an appeal with plenty of photos and user manual of this product clearly stating "It is not a medical device" on its box and in it's user manual. I did not receive any explanation about my appeal. Has is been accepted or not?
The concern with the information you've provided surrounding the ASIN images where it clearly states EKG accurate on the detail page, this would imply that it can meet the same standard as a medical device or electrocardiogram. Unless you can provide additional or supporting documentation that this is safe for public use and is not a medical device or offering the same features as a medical device, the ASIN may not be eligible for reactivation. One of our policies regarding these types of issues, is if it is on the packaging, it may not be eligible for reactivation unless you can provide the above mentioned documentation.
The forums community and I are here to support you. Please let us know how we can help you from this point forward.
Emet.
