Sleeve, Limb, Compressible
The Sleeve, Limb, Compressible is a cardiovascular device that applies intermittent pneumatic compression to the limbs through an inflatable sleeve, used to prevent deep vein thrombosis (DVT) and improve venous return in patients who are immobile or at risk for thromboembolic complications. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification prior to marketing. It carries product code JOW and is regulated under 21 CFR 870.5800, within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- JOW
- Device Class
- FDA class 2
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 350 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250242 | Compression Therapy Device (LGT-2202DVT) | Apr 24, 2026 | Substantially Equivalent | Guangzhou Longest Medical Technology Co., Ltd. |
| K254267 | NanoPress 760A-BT (760A-BT) | Feb 24, 2026 | Substantially Equivalent | Mego Afek , Ltd. |
| K250974 | Bio Arterial Deluxe (IC-BAP-DX) | Dec 12, 2025 | Substantially Equivalent | Bio Compression Systems, Inc. |
| K250190 | Sequential Compression System (SCD600) | Dec 08, 2025 | Substantially Equivalent | Shenzhen Comen Medical Instruments Co.,Ltd |
| K251466 | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr | Oct 28, 2025 | Substantially Equivalent | Wellell, Inc. |
| K251446 | PlasmaFlow X Compression Sleeve Device (XPF0001) | Sep 17, 2025 | Substantially Equivalent | Manamed, LLC |
| K251086 | PnueAira (PNCU-01) | Aug 18, 2025 | Substantially Equivalent | Biotab, LLC |
| K250817 | Coretech Compression System (Coretech RHB3003) | Aug 08, 2025 | Substantially Equivalent | Vive Health, LLC |
| K241096 | Venera 608 Deep Vein Thrombosis (DVT) Prevention System | Jan 15, 2025 | Substantially Equivalent | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. |
| K240499 | ARTAIRA Arterial Compression Device (AACD01) | Oct 11, 2024 | Substantially Equivalent | Airos Medical, Inc. |
| K241746 | UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFF | Oct 04, 2024 | Substantially Equivalent | United Medical Resources, LLC |
| K232640 | Venowave VW5 | Jun 25, 2024 | Substantially Equivalent | Thermabright |
| K240125 | Therm-X (Home); Therm-X (AT) | Jun 21, 2024 | Substantially Equivalent | Zenith Technical Innovations |
| K234155 | Nimbl (model PD08-N1) | Jun 21, 2024 | Substantially Equivalent | Tactile Medical |
| K232270 | DVT Motion Pneumatic Compression Device | Mar 06, 2024 | Substantially Equivalent | Koge Micro Tech Co., Ltd. |
| K240011 | Lymphedema Compression | Feb 23, 2024 | Substantially Equivalent | Jkh Health Co., Ltd. |
| K223228 | Dayspring | Jan 04, 2024 | Substantially Equivalent | Koya Medical, Inc. |
| K232300 | ElastiMed SACS | Dec 22, 2023 | Substantially Equivalent | Elastimed , Ltd. |
| K231801 | MedHealth DVT compression Devices MHH900S/MHH900E | Dec 14, 2023 | Substantially Equivalent | Medhealth Medical Limited |
| K222823 | AeroDVx Arm System | Sep 07, 2023 | Substantially Equivalent | Sun Scientific, Inc. |
| K232006 | LEGACY® IPC | Aug 04, 2023 | Substantially Equivalent | Ig Technology, Ltd. |
| K230028 | Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly | Apr 03, 2023 | Substantially Equivalent | Cardinal Health200, LLC |
| K222158 | Capiflo 5001 | Jan 20, 2023 | Substantially Equivalent | K&L Distributing, Inc. |
| K223195 | AIROS 6P Sequential Compression Device | Dec 09, 2022 | Substantially Equivalent | Airos Medical, Inc. |
| K223193 | AIROS 8P Sequential Compression Device | Dec 09, 2022 | Substantially Equivalent | Airos Medical, Inc. |
| K221654 | medi pneumatic compression system (pcs)-genius (Model 652) | Jul 07, 2022 | Substantially Equivalent | Medi USA, LP |
| K213577 | VenAir, Sequential Compression System | Jun 28, 2022 | Substantially Equivalent | Apex Medical Corp. |
| K220761 | CIRCUL8 Connect DVT Prevention Device | Jun 03, 2022 | Substantially Equivalent | Ortho8, Inc. |
| K214053 | Amputee Garment for use with Lympha Press Optimal Plus | Apr 14, 2022 | Substantially Equivalent | Mego Afek AC , Ltd. |
| K213313 | Veinoflow SCD (Model: LBTK-M-I 5006) | Feb 09, 2022 | Substantially Equivalent | Dalian Labtek Science & Development Co., Ltd. |
| K211937 | SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System | Nov 18, 2021 | Substantially Equivalent | Jiangsu Synecoun Medical Technology Co., Ltd. |
| K212731 | Circul8 Pro | Nov 15, 2021 | Substantially Equivalent | Ortho8, Inc. |
| K203746 | Venen-trainer (Model: FM150, SFM90) | Nov 10, 2021 | Substantially Equivalent | Shenzhen Pango Electronic Co., Ltd. |
| K212287 | Dayspring Lite | Sep 21, 2021 | Substantially Equivalent | Koya Medical, Inc. |
| K211235 | CIRCUL8 Luxe DVT Prevention Device | Sep 08, 2021 | Substantially Equivalent | Ortho8, Inc. |
| K211200 | WoundExpress | Sep 03, 2021 | Substantially Equivalent | Huntleigh Healthcare , Ltd. |
| K211253 | PlasmaWave | May 26, 2021 | Substantially Equivalent | Manamed, Inc. |
| K210417 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | May 14, 2021 | Substantially Equivalent | Bio Compression Systems, Inc. |
| K203847 | Reprocessed Tri Pulse Compression Garment | May 07, 2021 | Substantially Equivalent | Renu Medical, Inc. |
| K210885 | Dayspring | Apr 23, 2021 | Substantially Equivalent | Koya Medical, Inc. |
| K203353 | DVT-PRO | Apr 22, 2021 | Substantially Equivalent | Daesung Maref Co., Ltd. |
| K203310 | SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System | Apr 02, 2021 | Substantially Equivalent | Jiangsu Synecoun Medical Technology Co., Ltd. |
| K203417 | DVT-4000S | Mar 28, 2021 | Substantially Equivalent | Daesung Maref Co., Ltd. |
| K203052 | Movement and Compressions System (the MAC System) | Mar 21, 2021 | Substantially Equivalent | Recovery Force, LLC |
| K193662 | Ezlymph, Ezlymph M | Feb 11, 2021 | Substantially Equivalent | Eezcare Medical Corp |
| K202839 | Overlapped Compression Therapy | Jan 21, 2021 | Substantially Equivalent | Jkh Health Co., Ltd. |
| K203178 | Flexitouch Plus System | Dec 20, 2020 | Substantially Equivalent | Tactile Systems Technology, Inc. (Dba Tactile Medical) |
| K203016 | DVT-2600 | Dec 05, 2020 | Substantially Equivalent | Daesung Maref Co., Ltd. |
| K201532 | B&J DVT Calf/Thigh Garments, Models 801/830 Series | Sep 19, 2020 | Substantially Equivalent | B&J Manufacturing , Ltd. |
| K201547 | B&J DVT Foot Garments, Models 820 Series | Sep 18, 2020 | Substantially Equivalent | B&J Manufacturing , Ltd. |
| K193476 | VariLymph 12 pro | Aug 19, 2020 | Substantially Equivalent | Slk Medical GmbH |
| K200353 | ManaFlow | Aug 06, 2020 | Substantially Equivalent | Manamed, Inc. |
| K200568 | B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System | Jul 10, 2020 | Substantially Equivalent | B&J Manufacturing , Ltd. |
| K200154 | B&J DVT Compression Devices MHH800/MHH800SQ | Jul 08, 2020 | Substantially Equivalent | B&J Manufacturing , Ltd. |
| K200285 | VenaOne | Jul 02, 2020 | Substantially Equivalent | Vena Group, LLC |
| K192337 | Zeroveno | Jun 22, 2020 | Substantially Equivalent | Dimedi Co., Ltd. |
| K193288 | Koya Ripple | Jun 16, 2020 | Substantially Equivalent | Koya, Inc. |
| K200564 | Aria System | Apr 03, 2020 | Substantially Equivalent | Inova Labs |
| K191856 | Compression Therapy Device | Mar 19, 2020 | Substantially Equivalent | Guangzhou Longest Science & Technology Co., Ltd. |
| K191937 | Ezvena IPC, Ezvena SQS | Jan 29, 2020 | Substantially Equivalent | Eezcare Medical Corp |
| K193069 | AIROS 6 Sequential Compression Device | Dec 04, 2019 | Substantially Equivalent | Airos Medical, Inc. |
| K193068 | AIROS 8 Sequential Compression Device | Dec 04, 2019 | Substantially Equivalent | Airos Medical, Inc. |
| K193020 | VenaPro Vascular Therapy System | Dec 04, 2019 | Substantially Equivalent | Innovamed Health, LLC |
| K191107 | Plexus | Aug 27, 2019 | Substantially Equivalent | Alleva Medical (D.G), Ltd. |
| K190975 | Plexus SCD110 Sequential Compression Device Sleeve | Jul 22, 2019 | Substantially Equivalent | Midway Medical, LLC |
| K183349 | AeroDVx System | Jul 19, 2019 | Substantially Equivalent | Sun Scientific, Inc. |
| K190976 | Radial Medical Compression System | Jul 12, 2019 | Substantially Equivalent | Radial Medical, Inc. |
| K190423 | Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System | Mar 19, 2019 | Substantially Equivalent | Devon Medical Products (Jiangsu), Ltd. |
| K182003 | Lympha Press Optimal Plus | Feb 27, 2019 | Substantially Equivalent | Mego Afek AC , Ltd. |
| K182578 | Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device | Feb 21, 2019 | Substantially Equivalent | Devon Medical Products (Jiangsu), Ltd. |
| K183631 | medi pneumatic compression system (pcs) brio (Model 651) | Jan 25, 2019 | Substantially Equivalent | Medi USA, LP |
| K183328 | Pulse Rx 2.0, Pulse Pro Rx 2.0 | Dec 21, 2018 | Substantially Equivalent | NormaTec Industries, LP |
| K182150 | Devon 52 Sequential Compression Device | Dec 18, 2018 | Substantially Equivalent | Devon Medical Products (Jiangsu), Ltd. |
| K181651 | Radial Medical Compression System | Oct 12, 2018 | Substantially Equivalent | Radial Medical, Inc. |
| K180248 | VascuEase IC-1200-WH | Aug 07, 2018 | Substantially Equivalent | Bio Compression Systems, Inc. |
| K181217 | VesoFlow Lite DVT Compression Device | Aug 05, 2018 | Substantially Equivalent | Caremed Supply, Inc. |
| K180389 | Venera 508 Deep Vein Thrombosis (DVT) Prevention System | Jun 29, 2018 | Substantially Equivalent | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. |
| K172779 | AIROS 8 Sequential Compression Device | Jun 22, 2018 | Substantially Equivalent | Airos Medical, Inc. |
| K172770 | AIROS 6 Sequential Compression Device | Jun 22, 2018 | Substantially Equivalent | Airos Medical, Inc. |
| K173012 | ANGIO-PRESS LITE DVT Compression Device | May 10, 2018 | Substantially Equivalent | Pegasus Medical Supply, Inc. |
| K172103 | Flowtron DVT5 Small Calf Garment | Mar 02, 2018 | Substantially Equivalent | Getinge (Suzhou) Co., Ltd. |
| K173528 | Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System | Feb 06, 2018 | Substantially Equivalent | Devon Medical Products (Jiangsu), Ltd. |
| K172030 | Devon 51 | Nov 27, 2017 | Substantially Equivalent | Devon Medical Products (Jiangsu), Ltd. |
| K172277 | Phlebo Press DVT Model | Nov 03, 2017 | Substantially Equivalent | Mego Afek AC , Ltd. |
| K170415 | Medline Hemo-Force DVT Compression Sleeve | Sep 08, 2017 | Substantially Equivalent | Medline Industries, Inc. |
| K171793 | Sequential Circulator SC-2004FC-OC | Aug 17, 2017 | Substantially Equivalent | Bio Compression Systems, Inc. |
| K170814 | Devon 24 | Jul 11, 2017 | Substantially Equivalent | Devon Medical Products (Jiangsu), Ltd. |
| K170658 | Lympha Press Optimal Plus | May 31, 2017 | Substantially Equivalent | Mego Afek AC , Ltd. |
| K170216 | Flexitouch System | May 26, 2017 | Substantially Equivalent | Tactile Systems Technology, Inc. (Dba Tactile Medical) |
| K162481 | RF1400 Active Compression Wrap | Feb 16, 2017 | Substantially Equivalent | Recovery Force, LLC |
| K163620 | Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves | Jan 19, 2017 | Substantially Equivalent | Covidien |
| K163055 | Reprocessed Kendall SCD Express Foot Cuff | Dec 23, 2016 | Substantially Equivalent | Covidien |
| K160180 | Intermittent Pneumatic Compression system | Nov 03, 2016 | Substantially Equivalent | Daesung Maref Co., Ltd. |
| K161105 | Reprocessed Compression Garments | Aug 18, 2016 | Substantially Equivalent | Covidien |
| K160431 | ActiveCare Home | Jul 13, 2016 | Substantially Equivalent | Medical Compression Systems (Dbn) , Ltd. |
| K161346 | NormaTec PCD-T and PCD-B | Jun 15, 2016 | Substantially Equivalent | NormaTec Industries, LP |
| K161209 | Cirona 6400 | May 31, 2016 | Substantially Equivalent | Devon Medical Products |
| K150980 | Venous Assist System | May 12, 2016 | Substantially Equivalent | Daesung Maref Co., Ltd. |
| K152228 | Hydroven 12, Hydroven 12 Garments | Apr 04, 2016 | Substantially Equivalent | Huntleigh Healthcare , Ltd. |
| K160318 | PlasmaFlow | Apr 01, 2016 | Substantially Equivalent | Manamed, Inc. |
| K150806 | PulseFlowDF | Dec 16, 2015 | Substantially Equivalent | Pulseflow Technologies |
| K151158 | ALP VasQcare Take Home System | Dec 10, 2015 | Substantially Equivalent | Currie Medical Specialties, Inc. |
| K151189 | Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System | Sep 18, 2015 | Substantially Equivalent | Devon Medical Products |
| K151377 | ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare | Jul 16, 2015 | Substantially Equivalent | Medical Compression System (Dbn) , Ltd. |
| K150953 | Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC | Jul 16, 2015 | Substantially Equivalent | Bio Compression Systems, Inc. |
| K143202 | ANGIO-PRESS DVT Compression Device Model Name: IPCS | Jul 07, 2015 | Substantially Equivalent | Pegasus Medical Supply, Inc. |
| K143438 | Flowtron ACS900 | Jun 23, 2015 | Substantially Equivalent | Getinge (Suzhou) Co., Ltd. |
| K143185 | entré Model PD08-U | May 07, 2015 | Substantially Equivalent | Tactile Systems Technology, Inc. |
| K143317 | Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) | Jan 20, 2015 | Substantially Equivalent | Currie Medical Specialties, Inc. |
| K143166 | Medline ReNewal Reprocessed Compression Limb Sleeves | Jan 16, 2015 | Substantially Equivalent | Surgical Instrument Service and Savings (Dba Medline Renewal |
| K142772 | Phlebo Press DVT 603 | Dec 16, 2014 | Substantially Equivalent | Mego Afek AC , Ltd. |
| K142728 | ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx HomeCare (ActiveCare+DTx-sub-category) | Dec 04, 2014 | Substantially Equivalent | Medical Compressions System (Dbn) , Ltd. |
| K141064 | VESOFLOW PLUS DVT COMPRESSION DEVICE | Dec 04, 2014 | Substantially Equivalent | Caremed Supply, Inc. |
| K141390 | INTERMITTENT PNEUMATIC COMPRESSION DEVICE | Nov 18, 2014 | Substantially Equivalent | Wuhan Landing Medical Hi-Tech, Ltd. |
| 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 | Nov 06, 2014 | Substantially Equivalent | Bio Compression Systems, Inc. |
| K141609 | PULSTAR LOGIX PUMP | Jul 15, 2014 | Substantially Equivalent | Albahealth, LLC |
| K140813 | REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES | Jul 15, 2014 | Substantially Equivalent | Covidien |
| K141578 | DEVON CIRONA 6200 DVT | Jun 27, 2014 | Substantially Equivalent | Devon Medical |
| K131416 | NOVOPRESS | Jun 23, 2014 | Substantially Equivalent | Milka, LLC |
| K141360 | TRIPLEPLAY PRO | Jun 12, 2014 | Substantially Equivalent | Wildcat Medical, Inc. |
| K140642 | PCD 737A | Jun 10, 2014 | Substantially Equivalent | Mego Afek AC , Ltd. |
| K140755 | ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS | May 08, 2014 | Substantially Equivalent | Medical Compression Systems (Dbn) , Ltd. |
| K140092 | CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES) | Apr 16, 2014 | Substantially Equivalent | Currie Medical Specialties, Inc. |
| K133119 | FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS | Feb 28, 2014 | Substantially Equivalent | Arjohuntleigh Polska SP Z.O.O. |
| K133274 | VENA PRO | Feb 12, 2014 | Substantially Equivalent | Innovamed Health, LLC |
| K131146 | ARTASSIST AND VENASSIST | Feb 10, 2014 | Substantially Equivalent | Aci Medical, LLC |
| K131387 | WRIGHT GRADIENT 52 - TORSO | Nov 20, 2013 | Substantially Equivalent | Wright Therapy Products, Inc. |
| K131420 | PETITE BASIC SYSTEM 701 ELT | Nov 01, 2013 | Substantially Equivalent | Mego Afek AC , Ltd. |
| K132360 | KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER | Aug 27, 2013 | Substantially Equivalent | Covidien |
| K123830 | INTERMITTENT PNEUMATIC COMPRESSION DEVICE | Aug 16, 2013 | Substantially Equivalent | Dalian Labtek Science & Development Co., Ltd. |
| K131306 | IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE | Jul 22, 2013 | Substantially Equivalent | Bio Compression Systems, Inc. |
| K131327 | BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM | Jul 18, 2013 | Substantially Equivalent | Bio Compression Systems, Inc. |
| K131046 | VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE SLEEVE (CALF) | Jul 18, 2013 | Substantially Equivalent | Venous Health Systems, Inc. |
| K131743 | CIRONA DVT FOOT GARMENT | Jul 01, 2013 | Substantially Equivalent | Devon Medical, Inc. |
| K130722 | AIRCAST VENAFLOW ELITE SYSTEM | Jun 20, 2013 | Substantially Equivalent | Djo, LLC |
| K131193 | ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM | Jun 18, 2013 | Substantially Equivalent | Tactile Systems Technology, Inc. |
| K130174 | DVTCARE CA5 | May 02, 2013 | Substantially Equivalent | Ossur Americas, Inc. |
| K130571 | DEVON CIRONA 6100 DVT | Apr 09, 2013 | Substantially Equivalent | Devon Medical, Inc. |
| K123959 | CIRCUFLOW 5150 | Feb 28, 2013 | Substantially Equivalent | Devon Medical, Inc. |
| K122640 | VPULSE | Feb 22, 2013 | Substantially Equivalent | Cothera, LLC |
| K123647 | CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE | Feb 14, 2013 | Substantially Equivalent | Devon Medical, Inc. |
| K123308 | PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM | Feb 08, 2013 | Substantially Equivalent | Albahealth, LLC |
| K122873 | VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS | Jan 15, 2013 | Substantially Equivalent | Caremed Supply, Inc. |
| K122609 | VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F | Dec 21, 2012 | Substantially Equivalent | Venous Health Systems, Inc. |
| K122330 | FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE | Dec 07, 2012 | Substantially Equivalent | Arjohuntleigh Polska SP Z.O.O. |
| K121962 | PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B | Oct 19, 2012 | Substantially Equivalent | Mego Afek AC , Ltd. |
| K122499 | AIRCAST VENAFLOW ELITE SYSTEM | Oct 18, 2012 | Substantially Equivalent | Djo, LLC |
| K122179 | VASOPRESS DVT LEG GARMENTS (STERILE) VASOPRESS DVT FOOT GARMENTS (STERILE) | Aug 20, 2012 | Substantially Equivalent | Compression Therapy Concepts |
| K121718 | A-V FOOT PUMP | Aug 17, 2012 | Substantially Equivalent | Dalian Labtek Science & Development Co., Ltd. |
| K121376 | COMPRESSION CARE FLIGHT | Jul 24, 2012 | Substantially Equivalent | Medical Minds, LLC |
| K121145 | RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME | Jun 12, 2012 | Substantially Equivalent | Renu Medical, Inc. |
| K120944 | KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER | May 31, 2012 | Substantially Equivalent | Covidien |
| K121001 | COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002) | Apr 17, 2012 | Substantially Equivalent | Novitas Medical, LLC |
| K120972 | FLEXITOUCH SYSTEM | Apr 13, 2012 | Substantially Equivalent | Tactile Systems Technology, Inc. |
| K113525 | ACTIVECARE DVT ACTIVECARE+SFT | Jan 31, 2012 | Substantially Equivalent | Medical Compression Systems (Dbn) , Ltd. |
| K112677 | THE VENOUS ASSIST SYSTEM | Jan 13, 2012 | Substantially Equivalent | Daesung Maref Co., Ltd. |
| K111748 | RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A | Nov 23, 2011 | Substantially Equivalent | Joy Long |
| K112838 | VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS | Nov 10, 2011 | Substantially Equivalent | Compression Therapy Concepts, Inc. |
| K110276 | POWERPRESS UNIT | Nov 09, 2011 | Substantially Equivalent | Hanuri Distribution, Inc. |
| K111720 | AVIAFIT | Sep 16, 2011 | Substantially Equivalent | Flowmedic , Ltd. |
| K112311 | ALP 501 RB PUMP SYSTEM | Sep 01, 2011 | Substantially Equivalent | Currie Medical Specialties, Inc. |
| K110977 | VESOFLOW | Aug 25, 2011 | Substantially Equivalent | Caremed Supply, Inc. |
| K110159 | ACTIVECARE SFT | May 12, 2011 | Substantially Equivalent | Medical Compression Systems (Dbn) , Ltd. |
| K110358 | VENODYNE V810 | May 05, 2011 | Substantially Equivalent | Microtek Medical, Inc. |
| K103113 | VASCULAIRE COMPRESSION SYSTEM | Feb 02, 2011 | Substantially Equivalent | Venous Health Systems, Inc. |
| K103187 | TRIPLEPLAY-VT VASCULAR THERAPY SYSTEM | Jan 26, 2011 | Substantially Equivalent | Wildcat Medical, Inc. |
| K102940 | VASCOPRESS SEQUENTIAL DVT PUMP | Jan 20, 2011 | Substantially Equivalent | Compression Therapy Concepts |
| K103247 | VASCUCOMP | Dec 10, 2010 | Substantially Equivalent | Thermotek, Inc. |
| K101035 | WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F, RD-1000C, RT 2000A, RT 2000B, RT 2000KF, RT 2000 | Oct 29, 2010 | Substantially Equivalent | Wmi Enterprises, LLC |
| K101355 | AUGEASE VASCULAR AUGMENTATION DEVICE | Oct 26, 2010 | Substantially Equivalent | Augdvt, LLC |
| K102737 | KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER | Oct 19, 2010 | Substantially Equivalent | Covidien, LLC |
| K102732 | VASOGRAD DVT COMPRESSION GARMENT | Oct 19, 2010 | Substantially Equivalent | Compression Therapy Concepts |
| K102582 | ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE | Oct 07, 2010 | Substantially Equivalent | Devon Medical, Inc. |
| K100969 | WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N | Sep 20, 2010 | Substantially Equivalent | Wmi Enterprises, LLC |
| K101702 | MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS | Aug 27, 2010 | Substantially Equivalent | Midwest Reprocessing Center, LLC |
| K101330 | MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE | Aug 27, 2010 | Substantially Equivalent | Midwest Reprocessing Center, LLC |
| K101915 | VASOPRESS SUPREME MINI MODEL VP500DM | Aug 06, 2010 | Substantially Equivalent | Compression Therapy Concepts, Inc. |
| K100909 | REPROCESSED COMPRESSION SLEEVES | Jul 23, 2010 | Substantially Equivalent | Ascent Healthcare Solutions |
| K101087 | REPROCESSED RESTEP COMPRESSION SLEEVES | Jul 16, 2010 | Substantially Equivalent | Ascent Heatlhcare Solutions |
| K101523 | CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE | Jun 17, 2010 | Substantially Equivalent | Devon Medical, Inc. |
| K100677 | LYMPHA PRESS 201MAX, MODEL 201MAX | May 20, 2010 | Substantially Equivalent | Mego Afek AC , Ltd. |
| K100521 | COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS | May 14, 2010 | Substantially Equivalent | Mego Afek AC , Ltd. |
| K100306 | KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES | May 04, 2010 | Substantially Equivalent | Covidien |
| K100446 | CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE | Mar 05, 2010 | Substantially Equivalent | Devon Medical, Inc. |
| K093658 | RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS | Jan 14, 2010 | Substantially Equivalent | Renu Medical, Inc. |
| K091700 | AIRCAST VENAFLOW ELITE SYSTEM | Jul 09, 2009 | Substantially Equivalent | Djo, LLC |
| K090308 | RESTEP DVY SYSTEM, MODEL RSP-101 | May 01, 2009 | Substantially Equivalent | Stortford Medical, LLC |
| K090074 | HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS | Apr 22, 2009 | Substantially Equivalent | Hygia Health Services, Inc. |
| K082149 | LYMPHA PRESS OPTIMAL, MODEL# 1201AP | Oct 06, 2008 | Substantially Equivalent | Mego Afek AC , Ltd. |
| K080551 | UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE | May 28, 2008 | Substantially Equivalent | University of Utah Hospitals and Clinics |
| K073028 | VENOWAVE MODELS VW5-6, VW5-10, VW5-20 AND VW5-30 | Mar 07, 2008 | Substantially Equivalent | Venowave, Inc. |
| K071763 | AMADEUS ADAPTIVE COMPRESSION THERAPY | Mar 07, 2008 | Substantially Equivalent | Convatec |
| K073013 | CTU676 DEVICE | Nov 21, 2007 | Substantially Equivalent | Compression Technologies Unlimited, Inc. |
| K072372 | PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE | Nov 21, 2007 | Substantially Equivalent | Mego Afek |
| K072666 | BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM | Nov 05, 2007 | Substantially Equivalent | Bio Compression Systems, Inc. |
| K071744 | AVIAFIT PULSATING LEGBAND | Sep 25, 2007 | Substantially Equivalent | Flowmedic , Ltd. |
| K071040 | WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPRESSION SYSTEMS | May 22, 2007 | Substantially Equivalent | Wright Linear Pump, Inc. |
| K070324 | IPC-BOOT | May 03, 2007 | Substantially Equivalent | C-Boot , Ltd. |
| K061814 | VASOPRESS DVT SYSTEM, MODEL VP500D | Nov 30, 2006 | Substantially Equivalent | Compression Therapy Concepts, Inc. |
| K062818 | FLEXITOUCH SYSTEM | Oct 06, 2006 | Substantially Equivalent | Tactile Systems Technology, Inc. |
| K061967 | SCD GARMENT, MODEL VP530 | Sep 25, 2006 | Substantially Equivalent | Compression Therapy Concepts, Inc. |
| K061866 | NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS | Aug 22, 2006 | Substantially Equivalent | Thermotek, Inc. |
| K061857 | MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR | Aug 01, 2006 | Substantially Equivalent | Bio Compression Systems, Inc. |
| K061125 | DVTCARE CA5 | May 23, 2006 | Substantially Equivalent | Doctors Orders |
| K052691 | SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES | May 17, 2006 | Substantially Equivalent | Suretek Medical |
| K052243 | PROACT WITH GEL OR PROACT 1 | Apr 12, 2006 | Substantially Equivalent | Proact, Inc. |
| K051227 | RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1 | Apr 07, 2006 | Substantially Equivalent | Renu Medical, Inc. |
| K051438 | VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM) | Apr 04, 2006 | Substantially Equivalent | Alliance Medical, Inc. |
| K060146 | ACTIVECARE ++ SYSTEM | Mar 08, 2006 | Substantially Equivalent | Medical Compression Systems (Dbn) , Ltd. |
| K060049 | REPROCESSED COMPRESSION SLEEVES | Feb 24, 2006 | Substantially Equivalent | Alliance Medical Corp. |
| K060091 | ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES | Feb 17, 2006 | Substantially Equivalent | Alliance Medical Corp. |
| K053575 | HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS | Feb 15, 2006 | Substantially Equivalent | Hygia Health Services, Inc. |
| K053316 | REPROCESSED COMPRESSION SLEEVES | Feb 13, 2006 | Substantially Equivalent | Alliance Medical Corp. |
| K060220 | PBS MODEL 701A COMPRESSION THERAPY DEVICE | Feb 09, 2006 | Substantially Equivalent | Mego Afek |
| K051805 | KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE | Oct 13, 2005 | Substantially Equivalent | Tyco Healthcare/Kendall |
| K050584 | GS-128 GRADIENT COMPRESSION SYSTEM | Mar 22, 2005 | Substantially Equivalent | Medmark Technologies, LLC |
| K043423 | MODEL SC-3008 SEQUENTIAL CIRCULATOR | Feb 01, 2005 | Substantially Equivalent | Bio Compression Systems, Inc. |
| K042217 | FLOWMEDIC, MODEL 220 | Jan 12, 2005 | Substantially Equivalent | Flowmedic (Israel), Ltd. |
| K041659 | C-BOOT | Oct 28, 2004 | Substantially Equivalent | C-Boot , Ltd. |
| K040649 | KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE | Jul 15, 2004 | Substantially Equivalent | Tyco Healthcare |
| K040511 | SCD EXPRESS PORTABLE COMPRESSION SYSTEM | Jun 28, 2004 | Substantially Equivalent | Tyco Healthcare/Kendall |
| K040065 | JSA'S REPROCESSED COMPRESSION SLEEVE DEVICES | Mar 29, 2004 | Substantially Equivalent | Jack Speer and Assoc., Inc. |
| K033615 | WFSI'S REPROCESSED COMPRESSION SLEEVE DEVICES | Feb 13, 2004 | Substantially Equivalent | Wheaton Franciscan Services Inc., Supply Chain |
| K031722 | JSA REPROCESSED COMPRESSION SLEEVE DEVICES | Nov 25, 2003 | Substantially Equivalent | Jack Speer and Assoc., Inc. |
| K031559 | RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES | Nov 12, 2003 | Substantially Equivalent | Renu Medical, Inc. |
| K031189 | UUHC REPROCESSED COMPRESSION SLEEVE DEVICES | Oct 16, 2003 | Substantially Equivalent | University of Utah Hospitals and Clinics |
| K024019 | ARTERIALFLOW SYSTEM, MODEL 32A | Jun 03, 2003 | Substantially Equivalent | Aircast, Inc. |
| K024087 | REPROCESSED COMPRESSION SLEEVES | Mar 11, 2003 | Substantially Equivalent | Alliance Medical Corp. |
| K024074 | REPROCESSED COMPRESSION SLEEVES | Mar 07, 2003 | Substantially Equivalent | Alliance Medical Corp. |
| K022340 | TRAVELAIR PORTABLE COMPRESSION SYSTEM | Feb 19, 2003 | Substantially Equivalent | Dynamic Air, Inc. |
| K023800 | VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017 | Feb 10, 2003 | Substantially Equivalent | Aircast, Inc. |
| K021654 | REPROCESSED COMPRESSION SLEEVE | Feb 05, 2003 | Substantially Equivalent | Alliance Medical, Inc. |
| K021509 | HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089 | Dec 24, 2002 | Substantially Equivalent | Hygia Health Services, Inc. |
| K023573 | WIZAIR COMPRESSION SYSTEM | Nov 21, 2002 | Substantially Equivalent | Medical Compression Systems (Dbn) , Ltd. |
| K022753 | REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS | Nov 14, 2002 | Substantially Equivalent | Medical Device Services |
| K022786 | DVT60 | Sep 19, 2002 | Substantially Equivalent | Huntleigh Healthcare, Inc. |
| K021528 | REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP | Aug 21, 2002 | Substantially Equivalent | Adven Medical |
| K020211 | BODY FORCE, MODEL BT 6000 | Jun 28, 2002 | Substantially Equivalent | Composites Solutions, Inc. |
| K013297 | AIRCAST, MODEL #3011 | Jun 14, 2002 | Substantially Equivalent | Millenium Reprocessing Services, Inc. |
| K012658 | REPROCESSED COMPRESSION LIMB SLEEVES | May 14, 2002 | Substantially Equivalent | Surgical Instruments Service and Savings, Inc. |
| K012979 | COMPRESSIBLE LIMB SLEEVE | May 08, 2002 | Substantially Equivalent | Medical Device Services, Inc. |
| K012614 | KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN | May 01, 2002 | Substantially Equivalent | Medical Instruments Technology, Inc. |
| K012657 | HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP | Apr 12, 2002 | Substantially Equivalent | Hygia Health Services, Inc. |
| K012654 | HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40 | Apr 12, 2002 | Substantially Equivalent | Hygia Health Services, Inc. |
| K012651 | HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200 | Apr 12, 2002 | Substantially Equivalent | Hygia Health Services, Inc. |
| K012650 | HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP | Apr 12, 2002 | Substantially Equivalent | Hygia Health Services, Inc. |
| K012956 | HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB | Apr 11, 2002 | Substantially Equivalent | Hygia Health Services, Inc. |
| K012417 | HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330, 5345, 5480 | Apr 08, 2002 | Substantially Equivalent | Hygia Health Services, Inc. |
| K012994 | WIZAIR DVT | Mar 27, 2002 | Substantially Equivalent | Medical Compression Systems (Dbn) , Ltd. |
| K010744 | FLOWTRON UNIVERSAL, MODEL AC600 | Mar 26, 2002 | Substantially Equivalent | Huntleigh Healthcare, Inc. |
| K012675 | REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS | Feb 12, 2002 | Substantially Equivalent | Adven Medical |
| K012597 | STERILMED REPROCESSED COMPRESSION SLEEVES | Feb 11, 2002 | Substantially Equivalent | Sterilmed, Inc. |
| K012621 | CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT | Feb 06, 2002 | Substantially Equivalent | Clearmedical, Inc. |
| K012616 | CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STANDARD), FG100/SM (SMALL), FG100-R (REGULAR | Feb 06, 2002 | Substantially Equivalent | Clearmedical, Inc. |
| K012612 | CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE | Feb 06, 2002 | Substantially Equivalent | Clearmedical, Inc. |
| K012606 | CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL THIGH-HIGH SCD SLEEVES, MEDIUM,SMALL, LARGE | Feb 06, 2002 | Substantially Equivalent | Clearmedical, Inc. |
| K012601 | CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF CUFF, CLEARMEDICAL/AIRCAST VENAFLOW THIGH | Feb 06, 2002 | Substantially Equivalent | Clearmedical, Inc. |
| K013436 | NORMATEC PCD | Dec 21, 2001 | Substantially Equivalent | Normatec, Inc. |
| K013331 | LYMPHA PRESS PLUS DEVICE | Nov 30, 2001 | Substantially Equivalent | Mego Afek |
| K011192 | COMPRESSIBLE LIMB SLEEVE | Nov 26, 2001 | Substantially Equivalent | Alliance Medical Corp. |
| K011318 | VENODYNE DVT ADVANTAGE PLUS | Oct 25, 2001 | Substantially Equivalent | Microtek Medical, Inc. |
| K003857 | STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES | Oct 18, 2001 | Substantially Equivalent | Sterilmed, Inc. |
| K012403 | VANGUARD REPROCESSED COMPRESSION GARMENT | Oct 17, 2001 | Substantially Equivalent | Vanguard Medical Concepts, Inc. |
| K012008 | STS RANGE , MODELS STS20,STS30,STS40 | Sep 21, 2001 | Substantially Equivalent | Huntleigh Healthcare, Inc. |
| K003828 | VASO PRESS DVT FOOT GARMENT #VP 520 | May 18, 2001 | Substantially Equivalent | Britt Corp., Inc. |
| K003701 | SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800) | Apr 05, 2001 | Substantially Equivalent | Sentech Medical Systems, Inc. |
| K003284 | PHLEBOPUMP, MODEL 1000 | Jan 17, 2001 | Substantially Equivalent | Prevent Products, Inc. |
| K001802 | VENODYNE DVT ADVANTAGE MODEL 610 | Jan 09, 2001 | Substantially Equivalent | Microtek Medical, Inc. |
| K002287 | WIZAIR COMPRESSION SYSTEM | Aug 25, 2000 | Substantially Equivalent | Medical Compression Systems (Dbn) , Ltd. |
| K991038 | VASO PRESS DVT SYSTEM, MODELS VP500, VP501 | Jun 22, 2000 | Substantially Equivalent | Britt Corp., Inc. |
| K993758 | PROAIR 3000 COMPRESSION SYSTEM | May 19, 2000 | Substantially Equivalent | Medical Compression Systems (Dbn) , Ltd. |
| K000303 | HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS FOR THE LIMB | May 16, 2000 | Substantially Equivalent | Healthcare Service and Supply |
| K000147 | CTC DVT-1 CALF GARMENT, MODEL DVT-1 | Apr 13, 2000 | Substantially Equivalent | Compression Therapy Concepts, Inc. |
| K992454 | VENAFLOW SYSTEM, MODEL 30A | Jan 13, 2000 | Substantially Equivalent | Aircast, Inc. |
| K992079 | KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325 | Sep 29, 1999 | Substantially Equivalent | The Kendall Company, L.P. |
| K973592 | WALKCARE P200 SYSTEM | May 20, 1999 | Substantially Equivalent | A.Stein - Regulatory Affairs Consulting |
| K983680 | TRINITY II SINGLE CHAMBER DVT PUMP | Apr 28, 1999 | Substantially Equivalent | Delphi Consulting Group |
| K981311 | COWBOY XV | Apr 23, 1999 | Substantially Equivalent | Kci New Technologies, Inc. |
| K974393 | VASO PRESS SYSTEM | Mar 19, 1999 | Substantially Equivalent | Britt Corp., Inc. |
| K981643 | RTM DVT PROSOFT CUFF MODEL NUMBER PS100 | Dec 14, 1998 | Substantially Equivalent | R.T. Medical Services, Inc. |
| K980600 | D903 AVANT ADULT HOLLOW FIBER OXYGENATOR | Aug 12, 1998 | Substantially Equivalent | Dideco S.P.A. |
| K971892 | BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651 | Aug 05, 1998 | Substantially Equivalent | Biomedical Horizons, Inc. |
| K980456 | JOBST ATHROMBIC PUMP SYSTEM 2600 | May 05, 1998 | Substantially Equivalent | Jobst A Beiersdorf Co. |
| K974318 | HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GAARMENTS FOR THE LIMB | Feb 13, 1998 | Substantially Equivalent | Healthcare Service and Supply |
| K965153 | HUNTLEIGH FP5000 SYSTEM MODEL FP5000 | Jan 26, 1998 | Substantially Equivalent | Huntleigh Healthcare, Inc. |
| K970922 | JOBST ATHROMBIC PUMP/SLEEVE | Jan 13, 1998 | Substantially Equivalent | Jobst A Beiersdorf Co. |
| K963957 | TRINITY DVT SYSTEM | Nov 04, 1997 | Substantially Equivalent | Delphi Consulting Group |
| K964238 | AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS | Sep 08, 1997 | Substantially Equivalent | Aircast, Inc. |
| K970014 | TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.) | Aug 06, 1997 | Substantially Equivalent | Delphi Consulting Group |
| K964425 | A-V IMPULSE SYSTEM MODEL 6060 | Jul 28, 1997 | Substantially Equivalent | Powell,Goldstein,Frazer & Murphy |
| K964188 | HEALTHCARE SERVICE AND SUPPLY PVA (PNEUMATIC VENOUS AUGMENTATION) FOOT GARMENT | May 06, 1997 | Substantially Equivalent | Healthcare Service and Supply |
| K961676 | AIRCAST VENAFLOW SYSTEM (MODIFICATION) | Mar 28, 1997 | Substantially Equivalent | Aircast, Inc. |
| K963067 | SOF. PRESS EPC 51 SYSTEM | Jan 28, 1997 | Substantially Equivalent | Gaymar Industries, Inc. |
| K963929 | JOBST ATHROMBIC PUMP SYSTEM 2100 | Jan 27, 1997 | Substantially Equivalent | Jobst A Beiersdorf Co. |
| K963672 | MODEL 90022 ROLLING STAND | Jan 06, 1997 | Substantially Equivalent | Augustine Medical, Inc. |
| K961405 | ALBA HEALTH PAS WRAP SYSTEM | Dec 26, 1996 | Substantially Equivalent | Alba-Waldensian, Inc. |
| K961891 | WLP SINGLE-SEGMENT VERSION WLP SOLO VII | Nov 06, 1996 | Substantially Equivalent | Wright Linear Pump, Inc. |
| K961797 | WLP GRADIENT SEQUENTIAL VERSION/WLP PROLITE/WLP WLP-II LITE | Nov 06, 1996 | Substantially Equivalent | Wright Linear Pump, Inc. |
| K961292 | WLP SEQUENTIAL VERSION MODEL WLP SOLO VI, WLP SOLO SEQUENTIAL | Nov 06, 1996 | Substantially Equivalent | Wright Linear Pump, Inc. |
| K954788 | EUREDUC PNEUMATIC DRAINAGE SYSTEM | Oct 28, 1996 | Substantially Equivalent | Eureduc |
| K961166 | FLOWTRON EXCEL PUMP | Oct 11, 1996 | Substantially Equivalent | Hne Healthcare, Inc. |
| K960902 | EUREDUC PNEUMATIC DRAINAGE SYSTEM MODEL TP03 | Sep 26, 1996 | Substantially Equivalent | Eureduc |
| K955853 | HEALTHCARE SERVICE & SUPPLY PUMP ALP 501 PUMP SYSTEM | Jun 25, 1996 | Substantially Equivalent | Healthcare Service and Supply |
| K950967 | M.I.C. | May 08, 1996 | Substantially Equivalent | V.V.T. Healthcare Technologies, Inc. |
| K953850 | REDOX | Mar 04, 1996 | Substantially Equivalent | Kinetic Concepts, Inc. |
| K942530 | ART-ASSIST MODEL AA-1000 | Feb 28, 1996 | Substantially Equivalent | Aci Medical, Inc. |
| K954489 | TRINITY SLEEVE(S) | Feb 22, 1996 | Substantially Equivalent | Delphi Consulting Group |
| K953648 | A-V IMPULSE SYSTEM MODEL 6060 | Feb 12, 1996 | Substantially Equivalent | Novamedix , Ltd. |
| K951683 | A-V IMPULSE SYSTEM MODEL 6060 | Oct 26, 1995 | Substantially Equivalent | Novamedix , Ltd. |
| K951684 | AIRPERFECT 1000 (SINGLE-USER SYSTEM), AIRPERFECT 2000 (MULTI-USER SYSTEM) | Oct 06, 1995 | Substantially Equivalent | Digital Air Corp. |
| K944567 | COWBOY X | Jun 21, 1995 | Substantially Equivalent | Kinetic Concepts, Inc. |
| K942796 | PRESSSION S III | Mar 24, 1995 | Substantially Equivalent | Chattanooga Group, Inc. |
| K942664 | KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM | Jan 17, 1995 | Substantially Equivalent | The Kendal Co. |
| K943392 | THERA-FLOW GRADIENT SEQUENTIAL PUMP | Dec 30, 1994 | Substantially Equivalent | Meds Systems, Inc. |
| K943287 | ACT-ONE ADVANCED COMPRESSION TECHNOLOGY FOOT PUMP | Dec 27, 1994 | Substantially Equivalent | Ndm Acquisition Corp. |
| K934639 | JOBST ATHROMBIC PUMP - SYSTEM 2500 | Feb 09, 1994 | Substantially Equivalent | Jobst Institute, Inc. |
| K933977 | AIRCAST EDEMAFLOW SYSTEM | Dec 07, 1993 | Substantially Equivalent | Aircast, Inc. |
| K930526 | INTERMITTENT COMPRESSION SYSTEM MODEL 5000 | Nov 18, 1993 | Substantially Equivalent | Advanced Instruments, Inc. |
| K932900 | AIRCAST VENAFLOW SYSTEM | Oct 25, 1993 | Substantially Equivalent | Aircast, Inc. |
| K933259 | SCD(R) CONTROLLER | Sep 13, 1993 | Substantially Equivalent | Kendall Healthcare Products Co. Div.Of Tyco Health |
| K932835 | KENDALL T.E.D./SCD SEQUENTIAL COMPRESSION DEVICE | Aug 06, 1993 | Substantially Equivalent | Kendall Healthcare Products Co. Div.Of Tyco Health |
| K932215 | COWBOY III | Jul 21, 1993 | Substantially Equivalent | Kinetic Concepts, Inc. |
| K924891 | PLEXUS PULSER I, PLEXUS PULSER II | Jun 07, 1993 | Substantially Equivalent | Dobre, Inc. |
| K925717 | CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVE | May 07, 1993 | Substantially Equivalent | Huntleigh Healthcare, Inc. |
| K921608 | PRESSSION, SEQUENTIAL | Dec 30, 1992 | Substantially Equivalent | Chattanooga Group, Inc. |
| K920308 | COWBOY II | Aug 24, 1992 | Substantially Equivalent | Kinetic Concepts, Inc. |
| K921562 | JOBST EXTREMITY PUMP SYSTEM 7500 | Jun 22, 1992 | Substantially Equivalent | Jobst Institute, Inc. |
| K914461 | A-V IMPULSE SYSTEM | Apr 15, 1992 | Substantially Equivalent | Novamedix , Ltd. |
| K913611 | COWBOY | Jan 13, 1992 | Substantially Equivalent | Kinetic Concepts, Inc. |
| K911853 | PULSATILE ANTI-EMBOLISM SYS.PUMP | Jul 22, 1991 | Substantially Equivalent | Baxter Healthcare Corp |
| K910188 | FLOWPLUS AC330 PUMP GARMENTS | May 28, 1991 | Substantially Equivalent | Huntleigh Technology, Inc. |
| K903894 | VENAPULSE MODELS VP-25 AND VP-50 | Apr 03, 1991 | Substantially Equivalent | Aci Medical, Inc. |
| K904267 | ZOEX ANTISHOCK TROUSERS | Mar 18, 1991 | Substantially Equivalent | Zoex Corp. |
| K895732 | JOBST ATHROMBIC PUMP(R) SYSTEM 2000 | Jan 26, 1990 | Substantially Equivalent | Jobst Institute, Inc. |
| K895278 | SCD KNEE IMMOBILIZER | Nov 30, 1989 | Substantially Equivalent | Kendall Healthcare Products Co. Div.Of Tyco Health |
| K890938 | KENDALL SCD THERAPEUTIC SYSTEM | May 19, 1989 | Substantially Equivalent | Kendall Healthcare Products Co. Div.Of Tyco Health |
| K881632 | FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT | Sep 26, 1988 | Substantially Equivalent | Huntleigh Technology, Inc. |
| K882683 | JOBST EXTREMITY PUMP(R) SYSTEM 7500 | Sep 20, 1988 | Substantially Equivalent | Jobst Institute, Inc. |
| K873997 | ANTI-SHOCK TROUSERS | Dec 15, 1987 | Substantially Equivalent | Simulaids, Inc. |
| K863581 | MODIFIED MODEL 5320 T.E.D. COMPRESSION LIMB | Oct 31, 1986 | Substantially Equivalent | The Kendal Co. |
| K841235 | MEDO MEDOMER MBF-100 II | Nov 19, 1984 | Substantially Equivalent | Medo U.S.A., Inc. |
| K830577 | LINEAR PUMP #4370975 | May 25, 1983 | Substantially Equivalent | Wright Linear Pump, Inc. |
| K821696 | THE SOFT PEDAL | Jul 14, 1982 | Substantially Equivalent | Habco Products, Inc. |
| K810338 | LYMPHA PRESS | Oct 20, 1981 | Substantially Equivalent | Mego Afek |
| K800337 | DVT PREVENTION SYS. MBE 22 PRESSURE U. | Mar 25, 1980 | Substantially Equivalent | Med-Bio Engineering, Inc. |
| K791894 | 3M BRAND TOTAL LEG COMPRESSION TLC SYS. | Nov 16, 1979 | Substantially Equivalent | 3M Company |
| K781358 | SEQUENTIAL CUFF INFLATION DEVICE | Sep 20, 1978 | Substantially Equivalent | Medasonics, Inc. |
| K781357 | T.E.D. SEQUENTIAL COMPRESSION SLEEVES | Sep 20, 1978 | Substantially Equivalent | Kendall Research Center |
| K770956 | PAS ANTI-EMBOLISM SYSTEM | Sep 12, 1977 | Substantially Equivalent | Hamilton Industries, Inc. |
| K771083 | SEQUENTIAL PRESSURE CUFF | Jul 21, 1977 | Substantially Equivalent | Gaymar Industries, Inc. |
FEI Numbers
This FDA classification entry is associated with 129 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 129 registration numbers. Click on an entry to view related FDA registrations.