Search Results

The device is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

The Device is defined as prescription device intended to to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. The Device consists of a solid stainless steel needle with handle attached to facilitate the delivery of acupunture treatment. The material for the Device is stainless steel wire 0Cr19Ni9, which complies with the Chinese National Standard GB2024-94 for acupuncture needles. The handles of the Device are in flat, ring, flower or tube shape and are made of different materials including copper, stainless steel, aluminum, and plastic. The length of the Device conforms to GB2024-94, which meets the needs for depth of insertion and manipulation. The diameters of the needle come in 0.16mm, 0.18mm, 0.25mm, 0.30mm, 0.35mm, 0.40mm, and 0.45mm, depending on the needs. The point of the needle is round, straight, and smooth and complies with GB2024-94. Each acupuncture needle is individually packaged, with or without a guide (insertion) tube. The Device is sterilized with Ethylene Oxide, whose residue on the surface of needle body meets clinical health requirements. The Device package is confirmed to remain stainless and aseptic in two years of shelf life at room temperature, normal pressure, and ≤80%RH. The Device is sterile, disposable, and for single use only. The material, sterility, and biocompatibility of the Device meet the general specifications and the criteria for single use acupuncture needle. In addition, the Device is designed such that it is compatible with the current acupuncture needles produced by other major acupuncture needle manufacturers.