(176 days)
The acupuncture needles devices licensed are used by practitioners which are intended to pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states.
Not Found
This document is a 510(k) clearance letter from the FDA for Acupuncture Needles, allowing them to be marketed based on substantial equivalence to existing devices. As such, it does not contain the detailed information about acceptance criteria and clinical study results typically found in a Premarket Approval (PMA) application or a more extensive 510(k) submission summary.
Therefore, I cannot provide the requested information. This document primarily focuses on regulatory clearance based on substantial equivalence, rather than a performance study demonstrating acceptance criteria.
§ 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.