510(k) K180956

Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator by Shenzhen Roundwhale Technology Co. , Ltd. — Product Code NUH

K180956 is an FDA 510(k) premarket notification submitted by Shenzhen Roundwhale Technology Co. , Ltd. for the device "Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator". The FDA issued a decision of Substantially Equivalent on June 7, 2018. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890. Shenzhen Roundwhale Technology Co. , Ltd. has at least 6 other 510(k) clearances on record.