510(k) K150903

EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural by Maanshan Bond Medical Instruments Co., Ltd. — Product Code MQX

K150903 is an FDA 510(k) premarket notification submitted by Maanshan Bond Medical Instruments Co., Ltd. for the device "EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural". The FDA issued a decision of Substantially Equivalent on July 15, 2015. The device falls under product code MQX (Needle, Acupuncture, Single Use), a Class II device regulated under 21 CFR 880.5580.