510(k) K955057

MODEL 1100 COLD THERAPY DEVICE by Smith And Nephew Donjoy, Inc. — Product Code ILO

K955057 is an FDA 510(k) premarket notification submitted by Smith And Nephew Donjoy, Inc. for the device "MODEL 1100 COLD THERAPY DEVICE". The FDA issued a decision of Substantially Equivalent for Some Indications on Mar 8, 1996. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Smith And Nephew Donjoy, Inc. has 14 other 510(k) clearances on record.