510(k) K970533

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

K970533 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "MODEL 1100 COLD THERAPY DEVICE". The FDA issued a decision of Substantially Equivalent on April 15, 1997. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.