Hello @Cooper_Amazon,

You helped a fellow seller to get a product reinstated. We lost our battle with Amazon regulation. The ASIN is B00EUZYON0.

The MYAID Femmax Vaginal Dilators are classified under FDA product code HDQ and are listed under Sec. 884.4530 Obstetric-gynecologic specialized manual instrument. This category includes fixed-size cervical dilators, which are designed to stretch the cervix, as per its definition:

"A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix."

As this device is classified as a Class I device, it is 510(k) exempt. The manufacturer is an FDA-registered entity, and the MYAID Femmax Vaginal Dilators are properly listed as compliant with the necessary regulations. It is important to note that as a Class I 510(k) exempt device, there is no requirement for premarket notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act.

Let me know if you need more info. Can you please escalate this?