ClearanceBrief
Panels › Cardiovascular › Product code JOW · Class 2

Sleeve, Limb, Compressible

Regulation 870.5800

8510(k)s in 12 months (354 all time)
0recalls in 12 months (32 all time)
30recalls that name a 510(k)
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Top companies in JOW

Company510(k)sRecalls
Bio Compression Systems, Inc.120
Covidien83
Mego Afek AC , Ltd.110
Hygia Health Services, Inc.90
Medical Compression Systems (Dbn) , Ltd.90
Alliance Medical Corp.80
Compression Therapy Concepts80
Devon Medical80
Aircast, Inc.70
Airos Medical, Inc.70
Decided510(k)Device and applicantCode
Sep 11, 2026K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)
Bio Compression Systems, Inc.
JOW
Aug 31, 2026K254217Aerloom
Evolym, LLC
JOW
Jul 31, 2026K253555Flexitouch® Plus Advanced Pneumatic Compression System
Tactile Medical
JOW
Jun 25, 2026K253386DVT Garment
Vistar Medical Supplies Co., Ltd., CN
JOW
Apr 24, 2026K250242Compression Therapy Device (LGT-2202DVT)
Guangzhou Longest Medical Technology Co., Ltd., CN
JOW
Feb 24, 2026K254267NanoPress 760A-BT (760A-BT)
Mego Afek , Ltd., IL
JOW
Dec 12, 2025K250974Bio Arterial Deluxe (IC-BAP-DX)
Bio Compression Systems, Inc.
JOW
Dec 8, 2025K250190Sequential Compression System (SCD600)
Shenzhen Comen Medical Instruments Co.,Ltd, CN
JOW
Oct 28, 2025K251466VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); V
Wellell, Inc., TW
JOW
Sep 17, 2025K251446PlasmaFlow X Compression Sleeve Device (XPF0001)
Manamed, LLC
JOW
Aug 18, 2025K251086PnueAira (PNCU-01)
Biotab, LLC
JOW
Aug 8, 2025K250817Coretech Compression System (Coretech RHB3003)
Vive Health, LLC
JOW
Jan 15, 2025K241096Venera 608 Deep Vein Thrombosis (DVT) Prevention System
Suzhou Minhua Medical Apparatus Supplies Co., Ltd., CN
JOW
Oct 11, 2024K240499ARTAIRA Arterial Compression Device (AACD01)
Airos Medical, Inc.
JOW
Oct 4, 2024K241746UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE
United Medical Resources, LLC
JOW
Jun 25, 2024K232640Venowave VW5
Thermabright
JOW
Jun 21, 2024K240125Therm-X (Home); Therm-X (AT)
Zenith Technical Innovations
JOW
Jun 21, 2024K234155Nimbl (model PD08-N1)
Tactile Medical
JOW
Mar 6, 2024K232270DVT Motion Pneumatic Compression Device
Koge Micro Tech Co., Ltd., TW
JOW
Feb 23, 2024K240011Lymphedema Compression
Jkh Health Co., Ltd., CN
JOW
Jan 4, 2024K223228Dayspring
Koya Medical, Inc.
JOW
Dec 22, 2023K232300ElastiMed SACS
Elastimed , Ltd., IL
JOW
Dec 14, 2023K231801MedHealth DVT compression Devices MHH900S/MHH900E
Medhealth Medical Limited, CN
JOW
Sep 7, 2023K222823AeroDVx Arm System
Sun Scientific, Inc.
JOW
Aug 4, 2023K232006LEGACY® IPC
Ig Technology, Ltd., GB
JOW
Apr 3, 2023K230028Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot
Cardinal Health200, LLC
JOW
Jan 20, 2023K222158Capiflo 5001
K&L Distributing, Inc.
JOW
Dec 9, 2022K223195AIROS 6P Sequential Compression Device
Airos Medical, Inc.
JOW
Dec 9, 2022K223193AIROS 8P Sequential Compression Device
Airos Medical, Inc.
JOW
Jul 7, 2022K221654medi pneumatic compression system (pcs)-genius (Model 652)
Medi USA, LP
JOW
Jun 28, 2022K213577VenAir, Sequential Compression System
Apex Medical Corp., TW
JOW
Jun 3, 2022K220761CIRCUL8 Connect DVT Prevention Device
Ortho8, Inc.
JOW
Apr 14, 2022K214053Amputee Garment for use with Lympha Press Optimal Plus
Mego Afek AC , Ltd., IL
JOW
Feb 9, 2022K213313Veinoflow SCD (Model: LBTK-M-I 5006)
Dalian Labtek Science & Development Co., Ltd., CN
JOW
Nov 18, 2021K211937SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System
Jiangsu Synecoun Medical Technology Co., Ltd., CN
JOW
Nov 15, 2021K212731Circul8 Pro
Ortho8, Inc.
JOW
Nov 10, 2021K203746Venen-trainer (Model: FM150, SFM90)
Shenzhen Pango Electronic Co., Ltd., CN
JOW
Sep 21, 2021K212287Dayspring Lite
Koya Medical, Inc.
JOW
Sep 8, 2021K211235CIRCUL8 Luxe DVT Prevention Device
Ortho8, Inc.
JOW
Sep 3, 2021K211200WoundExpress
Huntleigh Healthcare , Ltd., GB
JOW
May 26, 2021K211253PlasmaWave
Manamed, Inc.
JOW
May 14, 2021K210417Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
Bio Compression Systems, Inc.
JOW
May 7, 2021K203847Reprocessed Tri Pulse Compression Garment
Renu Medical, Inc.
JOW
Apr 23, 2021K210885Dayspring
Koya Medical, Inc.
JOW
Apr 22, 2021K203353DVT-PRO
Daesung Maref Co., Ltd., KR
JOW
Apr 2, 2021K203310SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System
Jiangsu Synecoun Medical Technology Co., Ltd., CN
JOW
Mar 28, 2021K203417DVT-4000S
Daesung Maref Co., Ltd., KR
JOW
Mar 21, 2021K203052Movement and Compressions System (the MAC System)
Recovery Force, LLC
JOW
Feb 11, 2021K193662Ezlymph, Ezlymph M
Eezcare Medical Corp, TW
JOW
Jan 21, 2021K202839Overlapped Compression Therapy
Jkh Health Co., Ltd., CN
JOW

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