510(k) K212989

Low-frequency Stimulator (Model: AST-645, AST-646) by Shenzhen Osto Technology Co., Ltd. — Product Code NUH

K212989 is an FDA 510(k) premarket notification submitted by Shenzhen Osto Technology Co., Ltd. for the device "Low-frequency Stimulator (Model: AST-645, AST-646)". The FDA issued a decision of Substantially Equivalent on Nov 22, 2021. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890. Shenzhen Osto Technology Co., Ltd. has 4 other 510(k) clearances on record.