510(k) K021509

HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089 by Hygia Health Services, Inc. — Product Code JOW

K021509 is an FDA 510(k) premarket notification submitted by Hygia Health Services, Inc. for the device "HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089". The FDA issued a decision of Substantially Equivalent on December 24, 2002. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Hygia Health Services, Inc. has at least 10 other 510(k) clearances on record.