510(k) K201645

Massage Compression Boots by Jkh USA, LLC — Product Code IRP

K201645 is an FDA 510(k) premarket notification submitted by Jkh USA, LLC for the device "Massage Compression Boots". The FDA issued a decision of Substantially Equivalent on September 15, 2020. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Jkh USA, LLC has at least 8 other 510(k) clearances on record.