Device Class Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)
Product Code Massager, Powered Inflatable Tube (IRP) (1) Pack, Hot Or Cold, Water Circulating (ILO) (1) Sleeve, Limb, Compressible (JOW) (1)