510k for Amazon Product Violation Flagged as Medical Device for face and neck massager
I'm looking to get help from any Amazon Mods. We own the brand and product listing for ASIN B0D5QC2RKJ.
After listing , my listing was active for more than 30 days. Once I changed listing picture. Immediatly Amazon flagged it as a medical device and requested 510k number.
FDA documentation clears shows that face and Neck massager is not in 510(k) list
Below exemption list shows one line item which matches with face and neck massager. So face and neck massager device is 510(k) exeption list
==>>PART 878 GENERAL AND PLASTIC SURGERY DEVICES
Also ,FDA link where list of devices available for which 510 (k) is required :
From above fda link of "Summary of Medical Devices Reclassified Since 2013" scetion
FDA has listed devices which are considred to be medical treatment devices. In that list face massager beauty device is not listed.
That clearly shows that 510 (k) is not required for this device.
Proof: Summary of Medical Devices Reclassified Since 2013 section in FDA reclassification link does not have face and neck massager beauty device
Still Amazon is asking 510(k). Not sure How do i convince them. Can any one help.
510k for Amazon Product Violation Flagged as Medical Device for face and neck massager
I'm looking to get help from any Amazon Mods. We own the brand and product listing for ASIN B0D5QC2RKJ.
After listing , my listing was active for more than 30 days. Once I changed listing picture. Immediatly Amazon flagged it as a medical device and requested 510k number.
FDA documentation clears shows that face and Neck massager is not in 510(k) list
Below exemption list shows one line item which matches with face and neck massager. So face and neck massager device is 510(k) exeption list
==>>PART 878 GENERAL AND PLASTIC SURGERY DEVICES
Also ,FDA link where list of devices available for which 510 (k) is required :
From above fda link of "Summary of Medical Devices Reclassified Since 2013" scetion
FDA has listed devices which are considred to be medical treatment devices. In that list face massager beauty device is not listed.
That clearly shows that 510 (k) is not required for this device.
Proof: Summary of Medical Devices Reclassified Since 2013 section in FDA reclassification link does not have face and neck massager beauty device
Still Amazon is asking 510(k). Not sure How do i convince them. Can any one help.
4件の返信
Seller_6bjVYWcQY0NnE
Forgot to add case number. Please find the case number #15708426881
Seller_QDBOMqTcOqDfT
Im having the exact same issue and seem to be having no luck proving it is 510k exempt
Emet_Amazon
Hello @Seller_6bjVYWcQY0NnE,
Thank you for posting your concern with a medical device concern.
I'm looking to get help from any Amazon Mods. We own the brand and product listing for ASIN B0D5QC2RKJ.
After listing , my listing was active for more than 30 days. Once I changed listing picture. Immediatly Amazon flagged it as a medical device and requested 510k number.
FDA documentation clears shows that face and Neck massager is not in 510(k) list
Below exemption list shows one line item which matches with face and neck massager. So face and neck massager device is 510(k) exeption list
I appreciate all this information, and the inclusion of your case. I do see you have provided some picture of the product packaging, the major concern I see is that your listing, product and packaging advertises that this is associated to supporting wrinkles. This implies that this is a medical device as it augments the body and or skin. Even if it only affects the skin such as removing wrinkles, it would be considered a medical use only device requiring proper documentation.
Although I cannot provide the URL from the FDA website for cosmetic products, here is their bullet point on the subject:
Some products are marketed with claims that they will make people look younger. But are these products cosmetics? It depends.
- Products intended to make people more attractive are generally cosmetics. For example, moisturizing is a cosmetic claim. So, if a product is intended to make lines and wrinkles less noticeable, simply by moisturizing the skin, it’s a cosmetic. Similarly, makeup or “primers” intended to make the signs of aging less noticeable just by hiding them are also cosmetics.
- But, products intended to affect the structure or function of the body, such as the skin, are drugs, or sometimes medical devices, even if they affect the appearance. So, if a product is intended, for example, to remove wrinkles or increase the skin’s production of collagen, it’s a drug or a medical device.
As the product and ASIN details both reference "Wrinkle Removal" on them, we cannot guarantee that this product will be eligible for reactivation or for sale on amazon. IF you can provide supporting documentation, it would need to surround the specific functionality of your product to ensure the product does not violate our policy or that of the FDA. If you can show proof that the product does not violate the policy the proper documentation, you will also be required to ensure the listing is updated and correct.
The forums community and I are here to support you. Please let us know how we can help you from this point forward.
Emet.
