510(k) K961425

BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS by Bio Compression Systems, Inc. — Product Code ILO

K961425 is an FDA 510(k) premarket notification submitted by Bio Compression Systems, Inc. for the device "BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS". The FDA issued a decision of Substantially Equivalent on October 28, 1996. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Bio Compression Systems, Inc. has at least 10 other 510(k) clearances on record.