Search Results

To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding an acupuncture needle (Qizhou Acupuncture Needle, K013926). It does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML-based medical device.

The document determines the device is substantially equivalent to legally marketed predicate devices, which means it doesn't require a new clinical study to establish safety and effectiveness, but rather demonstrates it's as safe and effective as a device already on the market.

Therefore, I cannot fulfill your request for the specific sections you've outlined, as they are not present in this regulatory document for a physical medical device.

Ask a specific question about this device