510(k) K092627

CT2011 SONICSTIMU PAIN RELIEF DEVICE by Shenzhen Dongdixin Technology Co., Ltd. — Product Code IMG

K092627 is an FDA 510(k) premarket notification submitted by Shenzhen Dongdixin Technology Co., Ltd. for the device "CT2011 SONICSTIMU PAIN RELIEF DEVICE". The FDA issued a decision of Substantially Equivalent on January 14, 2010. The device falls under product code IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5860. Shenzhen Dongdixin Technology Co., Ltd. has at least 10 other 510(k) clearances on record.