510(k) K012956

HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB by Hygia Health Services, Inc. — Product Code JOW

K012956 is an FDA 510(k) premarket notification submitted by Hygia Health Services, Inc. for the device "HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB". The FDA issued a decision of Substantially Equivalent on April 11, 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.