510(k) K171978

Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 by Shenzhen Dongdixin Technology Co., Ltd. — Product Code IPF

K171978 is an FDA 510(k) premarket notification submitted by Shenzhen Dongdixin Technology Co., Ltd. for the device "Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10". The FDA issued a decision of Substantially Equivalent on October 2, 2017. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Shenzhen Dongdixin Technology Co., Ltd. has at least 10 other 510(k) clearances on record.