(40 days)
The acupuncture needles are devices which are intended 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) clearance letter from the FDA for "HBW Acupuncture Needles". It does not describe any acceptance criteria or a study proving that a device meets such criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the provided text. The document is an FDA clearance letter, not a clinical study report or a summary of performance data.
§ 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.