Product code JOW
- Device name
- Sleeve, Limb, Compressible
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.5800
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250242 | Compression Therapy Device (LGT-2202DVT) | Guangzhou Longest Medical Technology Co., Ltd. | 2026-04-24 |
| K254267 | NanoPress 760A-BT (760A-BT) | Mego Afek , Ltd. | 2026-02-24 |
| K250974 | Bio Arterial Deluxe (IC-BAP-DX) | Bio Compression Systems, Inc. | 2025-12-12 |
| K250190 | Sequential Compression System (SCD600) | Shenzhen Comen Medical Instruments Co.,Ltd | 2025-12-08 |
| 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 / C... | Wellell, Inc. | 2025-10-28 |
| K251446 | PlasmaFlow X Compression Sleeve Device (XPF0001) | Manamed, LLC | 2025-09-17 |
| K251086 | PnueAira (PNCU-01) | Biotab, LLC | 2025-08-18 |
| K250817 | Coretech Compression System (Coretech RHB3003) | Vive Health, LLC | 2025-08-08 |
| K241096 | Venera 608 Deep Vein Thrombosis (DVT) Prevention System | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2025-01-15 |
| K240499 | ARTAIRA Arterial Compression Device (AACD01) | Airos Medical, Inc. | 2024-10-11 |
| 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 |
| K232640 | Venowave VW5 | Thermabright | 2024-06-25 |
| K234155 | Nimbl (model PD08-N1) | Tactile Medical | 2024-06-21 |
| K240125 | Therm-X (Home); Therm-X (AT) | Zenith Technical Innovations | 2024-06-21 |
| K232270 | DVT Motion Pneumatic Compression Device | Koge Micro Tech Co., Ltd. | 2024-03-06 |
| K240011 | Lymphedema Compression | Jkh Health Co., Ltd. | 2024-02-23 |
| K223228 | Dayspring | Koya Medical, Inc. | 2024-01-04 |
| K232300 | ElastiMed SACS | Elastimed , Ltd. | 2023-12-22 |
| K231801 | MedHealth DVT compression Devices MHH900S/MHH900E | Medhealth Medical Limited | 2023-12-14 |
| K222823 | AeroDVx Arm System | Sun Scientific, Inc. | 2023-09-07 |
| K232006 | LEGACY® IPC | Ig Technology, Ltd. | 2023-08-04 |
| 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 |
| K222158 | Capiflo 5001 | K&L Distributing, Inc. | 2023-01-20 |
| K223195 | AIROS 6P Sequential Compression Device | Airos Medical, Inc. | 2022-12-09 |
| K223193 | AIROS 8P Sequential Compression Device | Airos Medical, Inc. | 2022-12-09 |
| K221654 | medi pneumatic compression system (pcs)-genius (Model 652) | Medi USA, LP | 2022-07-07 |
| K213577 | VenAir, Sequential Compression System | Apex Medical Corp. | 2022-06-28 |
| K220761 | CIRCUL8 Connect DVT Prevention Device | Ortho8, Inc. | 2022-06-03 |
| K214053 | Amputee Garment for use with Lympha Press Optimal Plus | Mego Afek AC , Ltd. | 2022-04-14 |
| K213313 | Veinoflow SCD (Model: LBTK-M-I 5006) | Dalian Labtek Science & Development Co., Ltd. | 2022-02-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04719893351026 | Wellell | Wellell Inc. | 2026-03-17 |
| 10885380184901 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-07-25 |
| 10885380184918 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-07-25 |
| 10885380184925 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-07-25 |
| 10885380184895 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-07-25 |
| 08809315675697 | DVT-SERIES | DAESUNG MAREF CO.,LTD. | 2021-06-21 |
| 08809315675666 | DVT-4000S | DAESUNG MAREF CO.,LTD. | 2021-06-21 |
| 08809315675543 | DVT-SERIES | DAESUNG MAREF CO.,LTD. | 2021-06-21 |
| 08809315675536 | DVT-SERIES | DAESUNG MAREF CO.,LTD. | 2021-06-21 |
| 08809315675529 | DVT-SERIES | DAESUNG MAREF CO.,LTD. | 2021-06-21 |
| 08809315675512 | DVT-SERIES | DAESUNG MAREF CO.,LTD. | 2021-06-21 |
| 08809315675505 | DVT-SERIES | DAESUNG MAREF CO.,LTD. | 2021-06-21 |
| 08809315675499 | DVT-SERIES | DAESUNG MAREF CO.,LTD. | 2021-06-21 |
| 08809315675482 | DVT-SERIES | DAESUNG MAREF CO.,LTD. | 2021-06-21 |
| 08809315675475 | DVT-SERIES | DAESUNG MAREF CO.,LTD. | 2021-06-21 |
| 08809315675468 | DVT-SERIES | DAESUNG MAREF CO.,LTD. | 2021-06-21 |
| 08809315675451 | DVT-SERIES | DAESUNG MAREF CO.,LTD. | 2021-06-21 |
| 08809315675437 | DVT-2600 | DAESUNG MAREF CO.,LTD. | 2021-06-21 |
| 08809315675420 | DVT-2600 | DAESUNG MAREF CO.,LTD. | 2021-06-21 |
| 08809315675390 | DVT-SERIES | DAESUNG MAREF CO.,LTD. | 2021-06-21 |
| 08809315675383 | DVT-SERIES | DAESUNG MAREF CO.,LTD. | 2021-06-21 |
| 08809315675376 | DVT-SERIES | DAESUNG MAREF CO.,LTD. | 2021-06-21 |
| 08809315675369 | DVT-SERIES | DAESUNG MAREF CO.,LTD. | 2021-06-21 |
| 08809315675352 | DVT-SERIES | DAESUNG MAREF CO.,LTD. | 2021-06-21 |
| 08809315675345 | DVT-SERIES | DAESUNG MAREF CO.,LTD. | 2021-06-21 |
| 08809315675338 | DVT-SERIES | DAESUNG MAREF CO.,LTD. | 2021-06-21 |
| 08809315675642 | DVT-4000S | DAESUNG MAREF CO.,LTD. | 2021-04-09 |
| 08809315675659 | DVT-4000S | DAESUNG MAREF CO.,LTD. | 2021-04-09 |
| 07613327347517 | n/a | STRYKER SUSTAINABILITY SOLUTIONS, INC. | 2016-09-23 |
| 08033178250283 | RESERVOIR | SORIN GROUP ITALIA SRL | 2015-07-15 |