510(k) K012654

HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40 by Hygia Health Services, Inc. — Product Code JOW

K012654 is an FDA 510(k) premarket notification submitted by Hygia Health Services, Inc. for the device "HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40". The FDA issued a decision of Substantially Equivalent on April 12, 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.