510(k) K260944

ManaCold Compression System by Manamed, LLC — Product Code IRP

K260944 is an FDA 510(k) premarket notification submitted by Manamed, LLC for the device "ManaCold Compression System". The FDA issued a decision of Substantially Equivalent on August 12, 2026. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Manamed, LLC has at least 8 other 510(k) clearances on record.