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 3 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K071040 | WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPRESSION SYSTEMS | Wright Linear Pump, Inc. | 2007-05-22 | Traditional | PDF ↗ |
| K070324 | IPC-BOOT | C-Boot , Ltd. | 2007-05-03 | Special | PDF ↗ |
| K061814 | VASOPRESS DVT SYSTEM, MODEL VP500D | Compression Therapy Concepts, Inc. | 2006-11-30 | Traditional | PDF ↗ |
| K062818 | FLEXITOUCH SYSTEM | Tactile Systems Technology, Inc. | 2006-10-06 | Traditional | PDF ↗ |
| K061967 | SCD GARMENT, MODEL VP530 | Compression Therapy Concepts, Inc. | 2006-09-25 | Traditional | PDF ↗ |
| K061866 | NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS | Thermotek, Inc. | 2006-08-22 | Traditional | PDF ↗ |
| K061857 | MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR | Bio Compression Systems, Inc. | 2006-08-01 | Traditional | PDF ↗ |
| K061125 | DVTCARE CA5 | Doctors Orders | 2006-05-23 | Traditional | PDF ↗ |
| K052691 | SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES | Suretek Medical | 2006-05-17 | Traditional | PDF ↗ |
| K052243 | PROACT WITH GEL OR PROACT 1 | Proact, Inc. | 2006-04-12 | Traditional | PDF ↗ |
| K051227 | RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1 | Renu Medical, Inc. | 2006-04-07 | Traditional | PDF ↗ |
| K051438 | VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM) | Alliance Medical, Inc. | 2006-04-04 | Traditional | PDF ↗ |
| K060146 | ACTIVECARE ++ SYSTEM | Medical Compression Systems (Dbn) , Ltd. | 2006-03-08 | Traditional | PDF ↗ |
| K060049 | REPROCESSED COMPRESSION SLEEVES | Alliance Medical Corp. | 2006-02-24 | Traditional | PDF ↗ |
| K060091 | ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES | Alliance Medical Corp. | 2006-02-17 | Traditional | PDF ↗ |
| K053575 | HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS | Hygia Health Services, Inc. | 2006-02-15 | Traditional | PDF ↗ |
| K053316 | REPROCESSED COMPRESSION SLEEVES | Alliance Medical Corp. | 2006-02-13 | Traditional | PDF ↗ |
| K060220 | PBS MODEL 701A COMPRESSION THERAPY DEVICE | Mego Afek | 2006-02-09 | Special | PDF ↗ |
| K051805 | KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE | Tyco Healthcare/Kendall | 2005-10-13 | Traditional | PDF ↗ |
| K050584 | GS-128 GRADIENT COMPRESSION SYSTEM | Medmark Technologies, LLC | 2005-03-22 | Traditional | PDF ↗ |
| K043423 | MODEL SC-3008 SEQUENTIAL CIRCULATOR | Bio Compression Systems, Inc. | 2005-02-01 | Traditional | PDF ↗ |
| K042217 | FLOWMEDIC, MODEL 220 | Flowmedic (Israel), Ltd. | 2005-01-12 | Traditional | PDF ↗ |
| K041659 | C-BOOT | C-Boot , Ltd. | 2004-10-28 | Traditional | PDF ↗ |
| K040649 | KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE | Tyco Healthcare | 2004-07-15 | Traditional | PDF ↗ |
| K040511 | SCD EXPRESS PORTABLE COMPRESSION SYSTEM | Tyco Healthcare/Kendall | 2004-06-28 | Traditional | PDF ↗ |
| K040065 | JSA'S REPROCESSED COMPRESSION SLEEVE DEVICES | Jack Speer and Assoc., Inc. | 2004-03-29 | Traditional | PDF ↗ |
| K033615 | WFSI'S REPROCESSED COMPRESSION SLEEVE DEVICES | Wheaton Franciscan Services Inc., Supply Chain | 2004-02-13 | Traditional | PDF ↗ |
| K031722 | JSA REPROCESSED COMPRESSION SLEEVE DEVICES | Jack Speer and Assoc., Inc. | 2003-11-25 | Traditional | PDF ↗ |
| K031559 | RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES | Renu Medical, Inc. | 2003-11-12 | Traditional | PDF ↗ |
| K031189 | UUHC REPROCESSED COMPRESSION SLEEVE DEVICES | University of Utah Hospitals and Clinics | 2003-10-16 | Traditional | PDF ↗ |
| K024019 | ARTERIALFLOW SYSTEM, MODEL 32A | Aircast, Inc. | 2003-06-03 | Traditional | PDF ↗ |
| K024087 | REPROCESSED COMPRESSION SLEEVES | Alliance Medical Corp. | 2003-03-11 | Traditional | PDF ↗ |
| K024074 | REPROCESSED COMPRESSION SLEEVES | Alliance Medical Corp. | 2003-03-07 | Traditional | PDF ↗ |
| K022340 | TRAVELAIR PORTABLE COMPRESSION SYSTEM | Dynamic Air, Inc. | 2003-02-19 | Traditional | PDF ↗ |
| K023800 | VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017 | Aircast, Inc. | 2003-02-10 | Traditional | PDF ↗ |
| K021654 | REPROCESSED COMPRESSION SLEEVE | Alliance Medical, Inc. | 2003-02-05 | Traditional | PDF ↗ |
| K021509 | HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089 | Hygia Health Services, Inc. | 2002-12-24 | Abbreviated | PDF ↗ |
| K023573 | WIZAIR COMPRESSION SYSTEM | Medical Compression Systems (Dbn) , Ltd. | 2002-11-21 | Special | PDF ↗ |
| K022753 | REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS | Medical Device Services | 2002-11-14 | Traditional | PDF ↗ |
| K022786 | DVT60 | Huntleigh Healthcare, Inc. | 2002-09-19 | Special | PDF ↗ |
| K021528 | REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP | Adven Medical | 2002-08-21 | Traditional | PDF ↗ |
| K020211 | BODY FORCE, MODEL BT 6000 | Composites Solutions, Inc. | 2002-06-28 | Traditional | PDF ↗ |
| K013297 | AIRCAST, MODEL #3011 | Millenium Reprocessing Services, Inc. | 2002-06-14 | Traditional | PDF ↗ |
| K012658 | REPROCESSED COMPRESSION LIMB SLEEVES | Surgical Instruments Service and Savings, Inc. | 2002-05-14 | Traditional | PDF ↗ |
| K012979 | COMPRESSIBLE LIMB SLEEVE | Medical Device Services, Inc. | 2002-05-08 | Traditional | PDF ↗ |
| K012614 | KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN | Medical Instruments Technology, Inc. | 2002-05-01 | Traditional | PDF ↗ |
| K012657 | HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP | Hygia Health Services, Inc. | 2002-04-12 | Traditional | PDF ↗ |
| K012654 | HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40 | Hygia Health Services, Inc. | 2002-04-12 | Traditional | PDF ↗ |
| K012650 | HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP | Hygia Health Services, Inc. | 2002-04-12 | Traditional | PDF ↗ |
| K012651 | HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200 | Hygia Health Services, Inc. | 2002-04-12 | Traditional | PDF ↗ |
| K012956 | HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB | Hygia Health Services, Inc. | 2002-04-11 | Traditional | PDF ↗ |
| K012417 | HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330, 5345, 5480 | Hygia Health Services, Inc. | 2002-04-08 | Traditional | PDF ↗ |
| K012994 | WIZAIR DVT | Medical Compression Systems (Dbn) , Ltd. | 2002-03-27 | Traditional | PDF ↗ |
| K010744 | FLOWTRON UNIVERSAL, MODEL AC600 | Huntleigh Healthcare, Inc. | 2002-03-26 | Traditional | PDF ↗ |
| K012675 | REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS | Adven Medical | 2002-02-12 | Traditional | PDF ↗ |
| K012597 | STERILMED REPROCESSED COMPRESSION SLEEVES | Sterilmed, Inc. | 2002-02-11 | Traditional | PDF ↗ |
| K012601 | CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF CUFF, CLEARMEDICAL/AIRCAST VENAFLOW THIGH | Clearmedical, Inc. | 2002-02-06 | Traditional | PDF ↗ |
| K012606 | CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL THIGH-HIGH SCD SLEEVES, MEDIUM,SMALL, LARGE | Clearmedical, Inc. | 2002-02-06 | Traditional | PDF ↗ |
| K012612 | CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE | Clearmedical, Inc. | 2002-02-06 | Traditional | PDF ↗ |
| K012621 | CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT | Clearmedical, Inc. | 2002-02-06 | Traditional | PDF ↗ |
| K012616 | CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STANDARD), FG100/SM (SMALL), FG100-R (REGULAR | Clearmedical, Inc. | 2002-02-06 | Traditional | PDF ↗ |
| K013436 | NORMATEC PCD | Normatec, Inc. | 2001-12-21 | Traditional | PDF ↗ |
| K013331 | LYMPHA PRESS PLUS DEVICE | Mego Afek | 2001-11-30 | Traditional | PDF ↗ |
| K011192 | COMPRESSIBLE LIMB SLEEVE | Alliance Medical Corp. | 2001-11-26 | Traditional | PDF ↗ |
| K011318 | VENODYNE DVT ADVANTAGE PLUS | Microtek Medical, Inc. | 2001-10-25 | Traditional | PDF ↗ |
| K003857 | STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES | Sterilmed, Inc. | 2001-10-18 | Traditional | PDF ↗ |
| K012403 | VANGUARD REPROCESSED COMPRESSION GARMENT | Vanguard Medical Concepts, Inc. | 2001-10-17 | Traditional | PDF ↗ |
| K012008 | STS RANGE , MODELS STS20,STS30,STS40 | Huntleigh Healthcare, Inc. | 2001-09-21 | Traditional | PDF ↗ |
| K003828 | VASO PRESS DVT FOOT GARMENT #VP 520 | Britt Corp., Inc. | 2001-05-18 | Traditional | PDF ↗ |
| K003701 | SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800) | Sentech Medical Systems, Inc. | 2001-04-05 | Traditional | PDF ↗ |
| K003284 | PHLEBOPUMP, MODEL 1000 | Prevent Products, Inc. | 2001-01-17 | Traditional | PDF ↗ |
| K001802 | VENODYNE DVT ADVANTAGE MODEL 610 | Microtek Medical, Inc. | 2001-01-09 | Traditional | PDF ↗ |
| K002287 | WIZAIR COMPRESSION SYSTEM | Medical Compression Systems (Dbn) , Ltd. | 2000-08-25 | Special | PDF ↗ |
| K991038 | VASO PRESS DVT SYSTEM, MODELS VP500, VP501 | Britt Corp., Inc. | 2000-06-22 | Traditional | PDF ↗ |
| K993758 | PROAIR 3000 COMPRESSION SYSTEM | Medical Compression Systems (Dbn) , Ltd. | 2000-05-19 | Traditional | PDF ↗ |
| K000303 | HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS FOR THE LIMB | Healthcare Service and Supply | 2000-05-16 | Traditional | PDF ↗ |
| K000147 | CTC DVT-1 CALF GARMENT, MODEL DVT-1 | Compression Therapy Concepts, Inc. | 2000-04-13 | Traditional | PDF ↗ |
| K992454 | VENAFLOW SYSTEM, MODEL 30A | Aircast, Inc. | 2000-01-13 | Traditional | PDF ↗ |
| K992079 | KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325 | The Kendall Company, L.P. | 1999-09-29 | Special | PDF ↗ |
| K973592 | WALKCARE P200 SYSTEM | A.Stein - Regulatory Affairs Consulting | 1999-05-20 | Traditional | PDF ↗ |
| K983680 | TRINITY II SINGLE CHAMBER DVT PUMP | Delphi Consulting Group | 1999-04-28 | Traditional | PDF ↗ |
| K981311 | COWBOY XV | Kci New Technologies, Inc. | 1999-04-23 | Traditional | PDF ↗ |
| K974393 | VASO PRESS SYSTEM | Britt Corp., Inc. | 1999-03-19 | Traditional | PDF ↗ |
| K981643 | RTM DVT PROSOFT CUFF MODEL NUMBER PS100 | R.T. Medical Services, Inc. | 1998-12-14 | Traditional | PDF ↗ |
| K980600 | D903 AVANT ADULT HOLLOW FIBER OXYGENATOR | Dideco S.P.A. | 1998-08-12 | Traditional | PDF ↗ |
| K971892 | BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651 | Biomedical Horizons, Inc. | 1998-08-05 | Traditional | PDF ↗ |
| K980456 | JOBST ATHROMBIC PUMP SYSTEM 2600 | Jobst A Beiersdorf Co. | 1998-05-05 | Traditional | PDF ↗ |
| K974318 | HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GAARMENTS FOR THE LIMB | Healthcare Service and Supply | 1998-02-13 | Traditional | PDF ↗ |
| K965153 | HUNTLEIGH FP5000 SYSTEM MODEL FP5000 | Huntleigh Healthcare, Inc. | 1998-01-26 | Traditional | PDF ↗ |
| K970922 | JOBST ATHROMBIC PUMP/SLEEVE | Jobst A Beiersdorf Co. | 1998-01-13 | Traditional | PDF ↗ |
| K963957 | TRINITY DVT SYSTEM | Delphi Consulting Group | 1997-11-04 | Traditional | PDF ↗ |
| K964238 | AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS | Aircast, Inc. | 1997-09-08 | Traditional | PDF ↗ |
| K970014 | TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.) | Delphi Consulting Group | 1997-08-06 | Traditional | PDF ↗ |
| K964425 | A-V IMPULSE SYSTEM MODEL 6060 | Powell,Goldstein,Frazer & Murphy | 1997-07-28 | Traditional | PDF ↗ |
| K964188 | HEALTHCARE SERVICE AND SUPPLY PVA (PNEUMATIC VENOUS AUGMENTATION) FOOT GARMENT | Healthcare Service and Supply | 1997-05-06 | Traditional | PDF ↗ |
| K961676 | AIRCAST VENAFLOW SYSTEM (MODIFICATION) | Aircast, Inc. | 1997-03-28 | Traditional | PDF ↗ |
| K963067 | SOF. PRESS EPC 51 SYSTEM | Gaymar Industries, Inc. | 1997-01-28 | Traditional | PDF ↗ |
| K963929 | JOBST ATHROMBIC PUMP SYSTEM 2100 | Jobst A Beiersdorf Co. | 1997-01-27 | Traditional | PDF ↗ |
| K963672 | MODEL 90022 ROLLING STAND | Augustine Medical, Inc. | 1997-01-06 | Traditional | PDF ↗ |
| K961405 | ALBA HEALTH PAS WRAP SYSTEM | Alba-Waldensian, Inc. | 1996-12-26 | Traditional | PDF ↗ |
Product code JOW · Class II · Cardiovascular. Data: openFDA.