510(k) K162566

AIK Sterile Acupuncture Needles for Single Use by Changchun Aik Medical Devices Co., Ltd. — Product Code MQX

K162566 is an FDA 510(k) premarket notification submitted by Changchun Aik Medical Devices Co., Ltd. for the device "AIK Sterile Acupuncture Needles for Single Use". The FDA issued a decision of Substantially Equivalent on May 11, 2017. The device falls under product code MQX (Needle, Acupuncture, Single Use), a Class II device regulated under 21 CFR 880.5580.