(120 days)
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Kangnian Brand Acupuncture Needle
This document is a FDA 510(k) clearance letter for a Kangnian Brand Acupuncture Needle. It does not contain information about the acceptance criteria or a study proving the device meets those criteria, as it is a regulatory approval document rather than a performance study report.
Therefore, I cannot extract the requested information from the provided text.
§ 880.5580 Acupuncture needle.
(a)
Identification. An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.(b)
Classification. Class II (special controls). The device, when it is an acupuncture point locator or a single use acupuncture needle, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. Acupuncture needles must comply with the following special controls:(1) Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109,
(2) Device material biocompatibility, and
(3) Device sterility.