JOW · Class II · 21 CFR 870.5800

FDA Product Code JOW: Sleeve, Limb, Compressible

Leading manufacturers include Covidien, Airos Medical, Inc. and Alliance Medical Corp..

352
Total
352
Cleared
148d
Avg days
1977
Since
Stable submission activity - 13 submissions in the last 2 years
Review times increasing: avg 215d recently vs 145d historically

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

352 devices
1–24 of 352
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
Cleared Aug 04, 2023
LEGACY® IPC
K232006
Ig Technology, Ltd.
Cardiovascular · 29d
Cleared Apr 03, 2023
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
K230028
Cardinal Health200, LLC
Cardiovascular · 89d
Cleared Jan 20, 2023
Capiflo 5001
K222158
K&L Distributing, Inc.
Cardiovascular · 184d
Cleared Dec 09, 2022
AIROS 8P Sequential Compression Device
K223193
Airos Medical, Inc.
Cardiovascular · 57d

About Product Code JOW - Regulatory Context

510(k) Submission Activity

352 total 510(k) submissions under product code JOW since 1977, with 352 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 215 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 →