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DBC Dongbang Acupuncture Needles have been used for "the general practice of acupuncture without any other specific use or treatment" in the United States. These single-use-only acupuncture needles are "intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States."

The acupuncture needles manufactured by Dong Bang Medical Co., LTD in Korea have been imported and sold through interstate commerce in the USA since 1988 under the FDA labeling restrictions of "Caution: Federal law restricts this device to sale by or on the order of qualified practitioners as determined by the State." The subject of this 510(k) application, "DBC, Dong Bang Acupuncture Needles," is a y-ray or EOG sterile, non-pyrogen, stainless, and single use only acupuncture needle and is identical to the DBC brand needles, 510(k) K963300. The DBC, Dong Bang acupuncture needles have various type (pipe or spring) needle handles, and are packaged by bulk or single sealed blister.