510(k) K182136

Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) by Shenzhen Osto Technology Co., Ltd. — Product Code NUH

K182136 is an FDA 510(k) premarket notification submitted by Shenzhen Osto Technology Co., Ltd. for the device "Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)". The FDA issued a decision of Substantially Equivalent on Oct 10, 2019. 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.