510(k) Report

Devices descending from K021509

9 later devices reach Hygia Health Services Reprocessed Novamedix Impab Models 5065, 5075, 5087, 5089 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101330Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest…Midwest Reprocessing Center, LLC20100—
+1K053575Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot CuffsHygia Health Services, Inc.20063—
+1K031559Renu Medical Reporcessed Compressible Limb SleevesRenu Medical, Inc.20034—
+2K203847Reprocessed Tri Pulse Compression GarmentRenu Medical, Inc.20210—
+2K090074Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc.20091—
+2K051227Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1Renu Medical, Inc.20062—
+3K101702Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC20100—
+3K093658Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu Medical Vasopress Foot…Renu Medical, Inc.20100—
+3K080551University Health Care Processed Alternating Leg Pressure (Uhc Apl) Sleeve DeviceUniversity of Utah Hospitals and Clinics20080—