JOW · Class II · 21 CFR 870.5800

FDA Product Code JOW: Sleeve, Limb, Compressible

Leading manufacturers include Bio Compression Systems, Inc., Mego Afek AC , Ltd. and Medical Compression Systems (Dbn) , Ltd..

354
Total
354
Cleared
148d
Avg days
1977
Since
Stable submission activity - 13 submissions in the last 2 years
Review times increasing: avg 216d recently vs 145d historically

FDA 510(k) Cleared Sleeve, Limb, Compressible Devices (Product Code JOW)

354 devices
1–24 of 354
Cleared Oct 27, 2026
Nimbl™ Pneumatic Compression System
K260586
Tactile Medical
Cardiovascular · 249d
Cleared Sep 11, 2026
Sequential Circulator (SC-4004-DL, SC-4008-DL)
K261807
Bio Compression Systems, Inc.
Cardiovascular · 102d
Cleared Jul 31, 2026
Flexitouch® Plus Advanced Pneumatic Compression System
K253555
Tactile Medical
Cardiovascular · 259d
Cleared Jun 25, 2026
DVT Garment
K253386
Vistar Medical Supplies Co., Ltd.
Cardiovascular · 268d
Cleared Apr 24, 2026
Compression Therapy Device (LGT-2202DVT)
K250242
Guangzhou Longest Medical Technology Co., Ltd.
Cardiovascular · 452d
Cleared Feb 24, 2026
NanoPress 760A-BT (760A-BT)
K254267
Mego Afek , Ltd.
Cardiovascular · 56d
Cleared Dec 12, 2025
Bio Arterial Deluxe (IC-BAP-DX)
K250974
Bio Compression Systems, Inc.
Cardiovascular · 256d
Cleared Dec 08, 2025
Sequential Compression System (SCD600)
K250190
Shenzhen Comen Medical Instruments Co.,Ltd
Cardiovascular · 319d
Cleared Oct 28, 2025
VenAir, Sequential Compression System (9P-089000)
K251466
Wellell, Inc.
Cardiovascular · 168d
Cleared Sep 17, 2025
PlasmaFlow X Compression Sleeve Device (XPF0001)
K251446
Manamed, LLC
Cardiovascular · 131d
Cleared Aug 18, 2025
PnueAira (PNCU-01)
K251086
Biotab, LLC
Cardiovascular · 131d
Cleared Aug 08, 2025
Coretech Compression System (Coretech RHB3003)
K250817
Vive Health, LLC
Cardiovascular · 143d
Cleared Jan 15, 2025
Venera 608 Deep Vein Thrombosis (DVT) Prevention System
K241096
Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
Cardiovascular · 268d
Cleared Oct 11, 2024
ARTAIRA Arterial Compression Device (AACD01)
K240499
Airos Medical, Inc.
Cardiovascular · 234d
Cleared Oct 04, 2024
UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF
K241746
United Medical Resources, LLC
Cardiovascular · 108d
Cleared Jun 25, 2024
Venowave VW5
K232640
Thermabright
Cardiovascular · 305d
Cleared Jun 21, 2024
Nimbl (model PD08-N1)
K234155
Tactile Medical
Cardiovascular · 175d
Cleared Jun 21, 2024
Therm-X (Home)
K240125
Zenith Technical Innovations
Cardiovascular · 157d
Cleared Mar 06, 2024
DVT Motion Pneumatic Compression Device
K232270
Koge Micro Tech Co., Ltd.
Cardiovascular · 219d
Cleared Feb 23, 2024
Lymphedema Compression
K240011
Jkh Health Co., Ltd.
Cardiovascular · 52d
Cleared Jan 04, 2024
Dayspring
K223228
Koya Medical, Inc.
Cardiovascular · 443d
Cleared Dec 22, 2023
ElastiMed SACS
K232300
Elastimed , Ltd.
Cardiovascular · 143d
Cleared Dec 14, 2023
MedHealth DVT compression Devices MHH900S/MHH900E
K231801
Medhealth Medical Limited
Cardiovascular · 177d
Cleared Sep 07, 2023
AeroDVx Arm System
K222823
Sun Scientific, Inc.
Cardiovascular · 353d

About Product Code JOW - Regulatory Context

510(k) Submission Activity

354 total 510(k) submissions under product code JOW since 1977, with 354 receiving FDA clearance (average review time: 148 days).

Submission volume has remained relatively stable over the observed period, with 13 submissions in the last 24 months.

FDA 510(k) Review Time - JOW Product Code

Recent submissions under JOW have taken an average of 216 days to reach a decision - up from 145 days historically. Manufacturers should account for longer review timelines in current project planning.

JOW devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →