510(k) K012417

HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330, 5345, 5480 by Hygia Health Services, Inc. — Product Code JOW

K012417 is an FDA 510(k) premarket notification submitted by Hygia Health Services, Inc. for the device "HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330, 5345, 5480". The FDA issued a decision of Substantially Equivalent on April 8, 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.