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.
Classification. Class II (special controls). Acupuncture needles must comply with the following special controls:
Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109,
Device material biocompatibility, and
Device sterility.
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