510(k) K183702

Polar Care Wave by Breg, Inc. — Product Code IRP

K183702 is an FDA 510(k) premarket notification submitted by Breg, Inc. for the device "Polar Care Wave". The FDA issued a decision of Substantially Equivalent on March 1, 2019. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Breg, Inc. has at least 10 other 510(k) clearances on record.