FDA Product Code
FDA Product Code JOW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5800
510(k) Clearances — 354 records · page 2 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K161209 | Cirona 6400 | Devon Medical Products | 2016-05-31 | Special | PDF ↗ |
| K150980 | Venous Assist System | Daesung Maref Co., Ltd. | 2016-05-12 | Traditional | PDF ↗ |
| K152228 | Hydroven 12, Hydroven 12 Garments | Huntleigh Healthcare , Ltd. | 2016-04-04 | Traditional | PDF ↗ |
| K160318 | PlasmaFlow | Manamed, Inc. | 2016-04-01 | Traditional | PDF ↗ |
| K150806 | PulseFlowDF | Pulseflow Technologies | 2015-12-16 | Traditional | PDF ↗ |
| K151158 | ALP VasQcare Take Home System | Currie Medical Specialties, Inc. | 2015-12-10 | Traditional | PDF ↗ |
| K151189 | Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System | Devon Medical Products | 2015-09-18 | Traditional | PDF ↗ |
| K150953 | Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC | Bio Compression Systems, Inc. | 2015-07-16 | Special | PDF ↗ |
| K151377 | ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare | Medical Compression System (Dbn) , Ltd. | 2015-07-16 | Traditional | PDF ↗ |
| K143202 | ANGIO-PRESS DVT Compression Device Model Name: IPCS | Pegasus Medical Supply, Inc. | 2015-07-07 | Traditional | PDF ↗ |
| K143438 | Flowtron ACS900 | Getinge (Suzhou) Co., Ltd. | 2015-06-23 | Traditional | PDF ↗ |
| K143185 | entré Model PD08-U | Tactile Systems Technology, Inc. | 2015-05-07 | Traditional | PDF ↗ |
| K143317 | Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) | Currie Medical Specialties, Inc. | 2015-01-20 | Traditional | PDF ↗ |
| K143166 | Medline ReNewal Reprocessed Compression Limb Sleeves | Surgical Instrument Service and Savings (Dba Medline Renewal | 2015-01-16 | Special | PDF ↗ |
| K142772 | Phlebo Press DVT 603 | Mego Afek AC , Ltd. | 2014-12-16 | Traditional | PDF ↗ |
| K141064 | VESOFLOW PLUS DVT COMPRESSION DEVICE | Caremed Supply, Inc. | 2014-12-04 | Traditional | PDF ↗ |
| K142728 | ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx HomeCare (ActiveCare+DTx-sub-category) | Medical Compressions System (Dbn) , Ltd. | 2014-12-04 | Traditional | PDF ↗ |
| K141390 | INTERMITTENT PNEUMATIC COMPRESSION DEVICE | Wuhan Landing Medical Hi-Tech, Ltd. | 2014-11-18 | Traditional | PDF ↗ |
| K142640 | Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator | Bio Compression Systems, Inc. | 2014-11-06 | Traditional | PDF ↗ |
| K141609 | PULSTAR LOGIX PUMP | Albahealth, LLC | 2014-07-15 | Special | PDF ↗ |
| K140813 | REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES | Covidien | 2014-07-15 | Traditional | PDF ↗ |
| K141578 | DEVON CIRONA 6200 DVT | Devon Medical | 2014-06-27 | Traditional | PDF ↗ |
| K131416 | NOVOPRESS | Milka, LLC | 2014-06-23 | Traditional | PDF ↗ |
| K141360 | TRIPLEPLAY PRO | Wildcat Medical, Inc. | 2014-06-12 | Special | PDF ↗ |
| K140642 | PCD 737A | Mego Afek AC , Ltd. | 2014-06-10 | Traditional | PDF ↗ |
| K140755 | ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS | Medical Compression Systems (Dbn) , Ltd. | 2014-05-08 | Special | PDF ↗ |
| K140092 | CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES) | Currie Medical Specialties, Inc. | 2014-04-16 | Traditional | PDF ↗ |
| K133119 | FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS | Arjohuntleigh Polska SP Z.O.O. | 2014-02-28 | Traditional | PDF ↗ |
| K133274 | VENA PRO | Innovamed Health, LLC | 2014-02-12 | Traditional | PDF ↗ |
| K131146 | ARTASSIST AND VENASSIST | Aci Medical, LLC | 2014-02-10 | Traditional | PDF ↗ |
| K131387 | WRIGHT GRADIENT 52 - TORSO | Wright Therapy Products, Inc. | 2013-11-20 | Traditional | PDF ↗ |
| K131420 | PETITE BASIC SYSTEM 701 ELT | Mego Afek AC , Ltd. | 2013-11-01 | Traditional | PDF ↗ |
| K132360 | KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER | Covidien | 2013-08-27 | Special | PDF ↗ |
| K123830 | INTERMITTENT PNEUMATIC COMPRESSION DEVICE | Dalian Labtek Science & Development Co., Ltd. | 2013-08-16 | Traditional | PDF ↗ |
| K131306 | IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE | Bio Compression Systems, Inc. | 2013-07-22 | Traditional | PDF ↗ |
| K131046 | VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE SLEEVE (CALF) | Venous Health Systems, Inc. | 2013-07-18 | Traditional | PDF ↗ |
| K131327 | BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM | Bio Compression Systems, Inc. | 2013-07-18 | Traditional | PDF ↗ |
| K131743 | CIRONA DVT FOOT GARMENT | Devon Medical, Inc. | 2013-07-01 | Traditional | PDF ↗ |
| K130722 | AIRCAST VENAFLOW ELITE SYSTEM | Djo, LLC | 2013-06-20 | Traditional | PDF ↗ |
| K131193 | ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM | Tactile Systems Technology, Inc. | 2013-06-18 | Traditional | PDF ↗ |
| K130174 | DVTCARE CA5 | Ossur Americas, Inc. | 2013-05-02 | Traditional | PDF ↗ |
| K130571 | DEVON CIRONA 6100 DVT | Devon Medical, Inc. | 2013-04-09 | Traditional | PDF ↗ |
| K123959 | CIRCUFLOW 5150 | Devon Medical, Inc. | 2013-02-28 | Traditional | PDF ↗ |
| K122640 | VPULSE | Cothera, LLC | 2013-02-22 | Traditional | PDF ↗ |
| K123647 | CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE | Devon Medical, Inc. | 2013-02-14 | Traditional | PDF ↗ |
| K123308 | PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM | Albahealth, LLC | 2013-02-08 | Traditional | PDF ↗ |
| K122873 | VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS | Caremed Supply, Inc. | 2013-01-15 | Special | PDF ↗ |
| K122609 | VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F | Venous Health Systems, Inc. | 2012-12-21 | Traditional | PDF ↗ |
| K122330 | FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE | Arjohuntleigh Polska SP Z.O.O. | 2012-12-07 | Special | PDF ↗ |
| K121962 | PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B | Mego Afek AC , Ltd. | 2012-10-19 | Traditional | PDF ↗ |
| K122499 | AIRCAST VENAFLOW ELITE SYSTEM | Djo, LLC | 2012-10-18 | Traditional | PDF ↗ |
| K122179 | VASOPRESS DVT LEG GARMENTS (STERILE) VASOPRESS DVT FOOT GARMENTS (STERILE) | Compression Therapy Concepts | 2012-08-20 | Special | PDF ↗ |
| K121718 | A-V FOOT PUMP | Dalian Labtek Science & Development Co., Ltd. | 2012-08-17 | Traditional | PDF ↗ |
| K121376 | COMPRESSION CARE FLIGHT | Medical Minds, LLC | 2012-07-24 | Traditional | PDF ↗ |
| K121145 | RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME | Renu Medical, Inc. | 2012-06-12 | Traditional | PDF ↗ |
| K120944 | KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER | Covidien | 2012-05-31 | Traditional | PDF ↗ |
| K121001 | COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002) | Novitas Medical, LLC | 2012-04-17 | Traditional | PDF ↗ |
| K120972 | FLEXITOUCH SYSTEM | Tactile Systems Technology, Inc. | 2012-04-13 | Traditional | PDF ↗ |
| K113525 | ACTIVECARE DVT ACTIVECARE+SFT | Medical Compression Systems (Dbn) , Ltd. | 2012-01-31 | Traditional | PDF ↗ |
| K112677 | THE VENOUS ASSIST SYSTEM | Daesung Maref Co., Ltd. | 2012-01-13 | Traditional | PDF ↗ |
| K111748 | RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A | Joy Long | 2011-11-23 | Traditional | PDF ↗ |
| K112838 | VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS | Compression Therapy Concepts, Inc. | 2011-11-10 | Traditional | PDF ↗ |
| K110276 | POWERPRESS UNIT | Hanuri Distribution, Inc. | 2011-11-09 | Traditional | PDF ↗ |
| K111720 | AVIAFIT | Flowmedic , Ltd. | 2011-09-16 | Traditional | PDF ↗ |
| K112311 | ALP 501 RB PUMP SYSTEM | Currie Medical Specialties, Inc. | 2011-09-01 | Special | PDF ↗ |
| K110977 | VESOFLOW | Caremed Supply, Inc. | 2011-08-25 | Traditional | PDF ↗ |
| K110159 | ACTIVECARE SFT | Medical Compression Systems (Dbn) , Ltd. | 2011-05-12 | Traditional | PDF ↗ |
| K110358 | VENODYNE V810 | Microtek Medical, Inc. | 2011-05-05 | Traditional | PDF ↗ |
| K103113 | VASCULAIRE COMPRESSION SYSTEM | Venous Health Systems, Inc. | 2011-02-02 | Traditional | PDF ↗ |
| K103187 | TRIPLEPLAY-VT VASCULAR THERAPY SYSTEM | Wildcat Medical, Inc. | 2011-01-26 | Traditional | PDF ↗ |
| K102940 | VASCOPRESS SEQUENTIAL DVT PUMP | Compression Therapy Concepts | 2011-01-20 | Special | PDF ↗ |
| K103247 | VASCUCOMP | Thermotek, Inc. | 2010-12-10 | Traditional | PDF ↗ |
| K101035 | WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F, RD-1000C, RT 2000A, RT 2000B, RT 2000KF, RT 2000 | Wmi Enterprises, LLC | 2010-10-29 | Traditional | PDF ↗ |
| K101355 | AUGEASE VASCULAR AUGMENTATION DEVICE | Augdvt, LLC | 2010-10-26 | Traditional | PDF ↗ |
| K102737 | KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER | Covidien, LLC | 2010-10-19 | Special | PDF ↗ |
| K102732 | VASOGRAD DVT COMPRESSION GARMENT | Compression Therapy Concepts | 2010-10-19 | Special | PDF ↗ |
| K102582 | ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE | Devon Medical, Inc. | 2010-10-07 | Traditional | PDF ↗ |
| K100969 | WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N | Wmi Enterprises, LLC | 2010-09-20 | Traditional | PDF ↗ |
| K101702 | MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS | Midwest Reprocessing Center, LLC | 2010-08-27 | Traditional | PDF ↗ |
| K101330 | MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE | Midwest Reprocessing Center, LLC | 2010-08-27 | Traditional | PDF ↗ |
| K101915 | VASOPRESS SUPREME MINI MODEL VP500DM | Compression Therapy Concepts, Inc. | 2010-08-06 | Special | PDF ↗ |
| K100909 | REPROCESSED COMPRESSION SLEEVES | Ascent Healthcare Solutions | 2010-07-23 | Traditional | PDF ↗ |
| K101087 | REPROCESSED RESTEP COMPRESSION SLEEVES | Ascent Heatlhcare Solutions | 2010-07-16 | Traditional | PDF ↗ |
| K101523 | CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE | Devon Medical, Inc. | 2010-06-17 | Traditional | PDF ↗ |
| K100677 | LYMPHA PRESS 201MAX, MODEL 201MAX | Mego Afek AC , Ltd. | 2010-05-20 | Traditional | PDF ↗ |
| K100521 | COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS | Mego Afek AC , Ltd. | 2010-05-14 | Traditional | PDF ↗ |
| K100306 | KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES | Covidien | 2010-05-04 | Traditional | PDF ↗ |
| K100446 | CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE | Devon Medical, Inc. | 2010-03-05 | Traditional | PDF ↗ |
| K093658 | RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS | Renu Medical, Inc. | 2010-01-14 | Traditional | PDF ↗ |
| K091700 | AIRCAST VENAFLOW ELITE SYSTEM | Djo, LLC | 2009-07-09 | Special | PDF ↗ |
| K090308 | RESTEP DVY SYSTEM, MODEL RSP-101 | Stortford Medical, LLC | 2009-05-01 | Traditional | PDF ↗ |
| K090074 | HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS | Hygia Health Services, Inc. | 2009-04-22 | Traditional | PDF ↗ |
| K082149 | LYMPHA PRESS OPTIMAL, MODEL# 1201AP | Mego Afek AC , Ltd. | 2008-10-06 | Traditional | PDF ↗ |
| K080551 | UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE | University of Utah Hospitals and Clinics | 2008-05-28 | Traditional | PDF ↗ |
| K073028 | VENOWAVE MODELS VW5-6, VW5-10, VW5-20 AND VW5-30 | Venowave, Inc. | 2008-03-07 | Traditional | PDF ↗ |
| K071763 | AMADEUS ADAPTIVE COMPRESSION THERAPY | Convatec | 2008-03-07 | Traditional | PDF ↗ |
| K073013 | CTU676 DEVICE | Compression Technologies Unlimited, Inc. | 2007-11-21 | Traditional | PDF ↗ |
| K072372 | PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE | Mego Afek | 2007-11-21 | Traditional | PDF ↗ |
| K072666 | BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM | Bio Compression Systems, Inc. | 2007-11-05 | Traditional | PDF ↗ |
| K071744 | AVIAFIT PULSATING LEGBAND | Flowmedic , Ltd. | 2007-09-25 | Traditional | PDF ↗ |
Product code JOW · Class II · Cardiovascular. Data: openFDA.