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 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261807 | Sequential Circulator (SC-4004-DL, SC-4008-DL) | Bio Compression Systems, Inc. | 2026-09-11 | Traditional | PDF ↗ |
| K254217 | Aerloom | Evolym, LLC | 2026-08-31 | Traditional | PDF ↗ |
| K253555 | Flexitouch® Plus Advanced Pneumatic Compression System | Tactile Medical | 2026-07-31 | Traditional | PDF ↗ |
| K253386 | DVT Garment | Vistar Medical Supplies Co., Ltd. | 2026-06-25 | Traditional | PDF ↗ |
| K250242 | Compression Therapy Device (LGT-2202DVT) | Guangzhou Longest Medical Technology Co., Ltd. | 2026-04-24 | Traditional | PDF ↗ |
| K254267 | NanoPress 760A-BT (760A-BT) | Mego Afek , Ltd. | 2026-02-24 | Traditional | PDF ↗ |
| K250974 | Bio Arterial Deluxe (IC-BAP-DX) | Bio Compression Systems, Inc. | 2025-12-12 | Traditional | PDF ↗ |
| K250190 | Sequential Compression System (SCD600) | Shenzhen Comen Medical Instruments Co.,Ltd | 2025-12-08 | Traditional | PDF ↗ |
| 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 | Wellell, Inc. | 2025-10-28 | Special | PDF ↗ |
| K251446 | PlasmaFlow X Compression Sleeve Device (XPF0001) | Manamed, LLC | 2025-09-17 | Special | PDF ↗ |
| K251086 | PnueAira (PNCU-01) | Biotab, LLC | 2025-08-18 | Traditional | PDF ↗ |
| K250817 | Coretech Compression System (Coretech RHB3003) | Vive Health, LLC | 2025-08-08 | Traditional | PDF ↗ |
| K241096 | Venera 608 Deep Vein Thrombosis (DVT) Prevention System | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2025-01-15 | Traditional | PDF ↗ |
| K240499 | ARTAIRA Arterial Compression Device (AACD01) | Airos Medical, Inc. | 2024-10-11 | Traditional | PDF ↗ |
| 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 | United Medical Resources, LLC | 2024-10-04 | Traditional | PDF ↗ |
| K232640 | Venowave VW5 | Thermabright | 2024-06-25 | Special | PDF ↗ |
| K240125 | Therm-X (Home); Therm-X (AT) | Zenith Technical Innovations | 2024-06-21 | Special | PDF ↗ |
| K234155 | Nimbl (model PD08-N1) | Tactile Medical | 2024-06-21 | Traditional | PDF ↗ |
| K232270 | DVT Motion Pneumatic Compression Device | Koge Micro Tech Co., Ltd. | 2024-03-06 | Traditional | PDF ↗ |
| K240011 | Lymphedema Compression | Jkh Health Co., Ltd. | 2024-02-23 | Traditional | PDF ↗ |
| K223228 | Dayspring | Koya Medical, Inc. | 2024-01-04 | Traditional | PDF ↗ |
| K232300 | ElastiMed SACS | Elastimed , Ltd. | 2023-12-22 | Traditional | PDF ↗ |
| K231801 | MedHealth DVT compression Devices MHH900S/MHH900E | Medhealth Medical Limited | 2023-12-14 | Traditional | PDF ↗ |
| K222823 | AeroDVx Arm System | Sun Scientific, Inc. | 2023-09-07 | Traditional | PDF ↗ |
| K232006 | LEGACY® IPC | Ig Technology, Ltd. | 2023-08-04 | Traditional | PDF ↗ |
| 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 | Cardinal Health200, LLC | 2023-04-03 | Traditional | PDF ↗ |
| K222158 | Capiflo 5001 | K&L Distributing, Inc. | 2023-01-20 | Special | PDF ↗ |
| K223195 | AIROS 6P Sequential Compression Device | Airos Medical, Inc. | 2022-12-09 | Traditional | PDF ↗ |
| K223193 | AIROS 8P Sequential Compression Device | Airos Medical, Inc. | 2022-12-09 | Traditional | PDF ↗ |
| K221654 | medi pneumatic compression system (pcs)-genius (Model 652) | Medi USA, LP | 2022-07-07 | Traditional | PDF ↗ |
| K213577 | VenAir, Sequential Compression System | Apex Medical Corp. | 2022-06-28 | Traditional | PDF ↗ |
| K220761 | CIRCUL8 Connect DVT Prevention Device | Ortho8, Inc. | 2022-06-03 | Special | PDF ↗ |
| K214053 | Amputee Garment for use with Lympha Press Optimal Plus | Mego Afek AC , Ltd. | 2022-04-14 | Traditional | PDF ↗ |
| K213313 | Veinoflow SCD (Model: LBTK-M-I 5006) | Dalian Labtek Science & Development Co., Ltd. | 2022-02-09 | Traditional | PDF ↗ |
| K211937 | SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System | Jiangsu Synecoun Medical Technology Co., Ltd. | 2021-11-18 | Traditional | PDF ↗ |
| K212731 | Circul8 Pro | Ortho8, Inc. | 2021-11-15 | Special | PDF ↗ |
| K203746 | Venen-trainer (Model: FM150, SFM90) | Shenzhen Pango Electronic Co., Ltd. | 2021-11-10 | Traditional | PDF ↗ |
| K212287 | Dayspring Lite | Koya Medical, Inc. | 2021-09-21 | Special | PDF ↗ |
| K211235 | CIRCUL8 Luxe DVT Prevention Device | Ortho8, Inc. | 2021-09-08 | Traditional | PDF ↗ |
| K211200 | WoundExpress | Huntleigh Healthcare , Ltd. | 2021-09-03 | Traditional | PDF ↗ |
| K211253 | PlasmaWave | Manamed, Inc. | 2021-05-26 | Special | PDF ↗ |
| K210417 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | Bio Compression Systems, Inc. | 2021-05-14 | Traditional | PDF ↗ |
| K203847 | Reprocessed Tri Pulse Compression Garment | Renu Medical, Inc. | 2021-05-07 | Traditional | PDF ↗ |
| K210885 | Dayspring | Koya Medical, Inc. | 2021-04-23 | Special | PDF ↗ |
| K203353 | DVT-PRO | Daesung Maref Co., Ltd. | 2021-04-22 | Special | PDF ↗ |
| K203310 | SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System | Jiangsu Synecoun Medical Technology Co., Ltd. | 2021-04-02 | Traditional | PDF ↗ |
| K203417 | DVT-4000S | Daesung Maref Co., Ltd. | 2021-03-28 | Traditional | PDF ↗ |
| K203052 | Movement and Compressions System (the MAC System) | Recovery Force, LLC | 2021-03-21 | Traditional | PDF ↗ |
| K193662 | Ezlymph, Ezlymph M | Eezcare Medical Corp | 2021-02-11 | Abbreviated | PDF ↗ |
| K202839 | Overlapped Compression Therapy | Jkh Health Co., Ltd. | 2021-01-21 | Traditional | PDF ↗ |
| K203178 | Flexitouch Plus System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2020-12-20 | Traditional | PDF ↗ |
| K203016 | DVT-2600 | Daesung Maref Co., Ltd. | 2020-12-05 | Special | PDF ↗ |
| K201532 | B&J DVT Calf/Thigh Garments, Models 801/830 Series | B&J Manufacturing , Ltd. | 2020-09-19 | Traditional | PDF ↗ |
| K201547 | B&J DVT Foot Garments, Models 820 Series | B&J Manufacturing , Ltd. | 2020-09-18 | Traditional | PDF ↗ |
| K193476 | VariLymph 12 pro | Slk Medical GmbH | 2020-08-19 | Traditional | PDF ↗ |
| K200353 | ManaFlow | Manamed, Inc. | 2020-08-06 | Traditional | PDF ↗ |
| K200568 | B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System | B&J Manufacturing , Ltd. | 2020-07-10 | Traditional | PDF ↗ |
| K200154 | B&J DVT Compression Devices MHH800/MHH800SQ | B&J Manufacturing , Ltd. | 2020-07-08 | Traditional | PDF ↗ |
| K200285 | VenaOne | Vena Group, LLC | 2020-07-02 | Traditional | PDF ↗ |
| K192337 | Zeroveno | Dimedi Co., Ltd. | 2020-06-22 | Traditional | PDF ↗ |
| K193288 | Koya Ripple | Koya, Inc. | 2020-06-16 | Traditional | PDF ↗ |
| K200564 | Aria System | Inova Labs | 2020-04-03 | Traditional | PDF ↗ |
| K191856 | Compression Therapy Device | Guangzhou Longest Science & Technology Co., Ltd. | 2020-03-19 | Traditional | PDF ↗ |
| K191937 | Ezvena IPC, Ezvena SQS | Eezcare Medical Corp | 2020-01-29 | Traditional | PDF ↗ |
| K193068 | AIROS 8 Sequential Compression Device | Airos Medical, Inc. | 2019-12-04 | Special | PDF ↗ |
| K193020 | VenaPro Vascular Therapy System | Innovamed Health, LLC | 2019-12-04 | Special | PDF ↗ |
| K193069 | AIROS 6 Sequential Compression Device | Airos Medical, Inc. | 2019-12-04 | Special | PDF ↗ |
| K191107 | Plexus | Alleva Medical (D.G), Ltd. | 2019-08-27 | Traditional | PDF ↗ |
| K190975 | Plexus SCD110 Sequential Compression Device Sleeve | Midway Medical, LLC | 2019-07-22 | Traditional | PDF ↗ |
| K183349 | AeroDVx System | Sun Scientific, Inc. | 2019-07-19 | Traditional | PDF ↗ |
| K190976 | Radial Medical Compression System | Radial Medical, Inc. | 2019-07-12 | Special | PDF ↗ |
| K190423 | Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System | Devon Medical Products (Jiangsu), Ltd. | 2019-03-19 | Special | PDF ↗ |
| K182003 | Lympha Press Optimal Plus | Mego Afek AC , Ltd. | 2019-02-27 | Traditional | PDF ↗ |
| K182578 | Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device | Devon Medical Products (Jiangsu), Ltd. | 2019-02-21 | Traditional | PDF ↗ |
| K183631 | medi pneumatic compression system (pcs) brio (Model 651) | Medi USA, LP | 2019-01-25 | Traditional | PDF ↗ |
| K183328 | Pulse Rx 2.0, Pulse Pro Rx 2.0 | NormaTec Industries, LP | 2018-12-21 | Traditional | PDF ↗ |
| K182150 | Devon 52 Sequential Compression Device | Devon Medical Products (Jiangsu), Ltd. | 2018-12-18 | Special | PDF ↗ |
| K181651 | Radial Medical Compression System | Radial Medical, Inc. | 2018-10-12 | Traditional | PDF ↗ |
| K180248 | VascuEase IC-1200-WH | Bio Compression Systems, Inc. | 2018-08-07 | Traditional | PDF ↗ |
| K181217 | VesoFlow Lite DVT Compression Device | Caremed Supply, Inc. | 2018-08-05 | Traditional | PDF ↗ |
| K180389 | Venera 508 Deep Vein Thrombosis (DVT) Prevention System | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2018-06-29 | Traditional | PDF ↗ |
| K172779 | AIROS 8 Sequential Compression Device | Airos Medical, Inc. | 2018-06-22 | Traditional | PDF ↗ |
| K172770 | AIROS 6 Sequential Compression Device | Airos Medical, Inc. | 2018-06-22 | Traditional | PDF ↗ |
| K173012 | ANGIO-PRESS LITE DVT Compression Device | Pegasus Medical Supply, Inc. | 2018-05-10 | Traditional | PDF ↗ |
| K172103 | Flowtron DVT5 Small Calf Garment | Getinge (Suzhou) Co., Ltd. | 2018-03-02 | Traditional | PDF ↗ |
| K173528 | Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System | Devon Medical Products (Jiangsu), Ltd. | 2018-02-06 | Special | PDF ↗ |
| K172030 | Devon 51 | Devon Medical Products (Jiangsu), Ltd. | 2017-11-27 | Traditional | PDF ↗ |
| K172277 | Phlebo Press DVT Model | Mego Afek AC , Ltd. | 2017-11-03 | Traditional | PDF ↗ |
| K170415 | Medline Hemo-Force DVT Compression Sleeve | Medline Industries, Inc. | 2017-09-08 | Traditional | PDF ↗ |
| K171793 | Sequential Circulator SC-2004FC-OC | Bio Compression Systems, Inc. | 2017-08-17 | Special | PDF ↗ |
| K170814 | Devon 24 | Devon Medical Products (Jiangsu), Ltd. | 2017-07-11 | Traditional | PDF ↗ |
| K170658 | Lympha Press Optimal Plus | Mego Afek AC , Ltd. | 2017-05-31 | Traditional | PDF ↗ |
| K170216 | Flexitouch System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2017-05-26 | Traditional | PDF ↗ |
| K162481 | RF1400 Active Compression Wrap | Recovery Force, LLC | 2017-02-16 | Traditional | PDF ↗ |
| K163620 | Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves | Covidien | 2017-01-19 | Special | PDF ↗ |
| K163055 | Reprocessed Kendall SCD Express Foot Cuff | Covidien | 2016-12-23 | Traditional | PDF ↗ |
| K160180 | Intermittent Pneumatic Compression system | Daesung Maref Co., Ltd. | 2016-11-03 | Special | PDF ↗ |
| K161105 | Reprocessed Compression Garments | Covidien | 2016-08-18 | Traditional | PDF ↗ |
| K160431 | ActiveCare Home | Medical Compression Systems (Dbn) , Ltd. | 2016-07-13 | Traditional | PDF ↗ |
| K161346 | NormaTec PCD-T and PCD-B | NormaTec Industries, LP | 2016-06-15 | Traditional | PDF ↗ |
Product code JOW · Class II · Cardiovascular. Data: openFDA.