Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart F — Cardiovascular Therapeutic Devices](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices) → [21 CFR 870.5800](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5800) → JOW — Sleeve, Limb, Compressible

# JOW · Sleeve, Limb, Compressible

_Cardiovascular · 21 CFR 870.5800 · Class 2_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/JOW

## Overview

- **Product Code:** JOW
- **Device Name:** Sleeve, Limb, Compressible
- **Regulation:** [21 CFR 870.5800](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5800)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (20 of 354)

Showing 20 most recent of 354 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K261807](/device/K261807.md) | Sequential Circulator (SC-4004-DL, SC-4008-DL) | Bio Compression Systems, Inc. | Sep 11, 2026 | SESE |
| [K254217](/device/K254217.md) | Aerloom | Evolym, LLC | Aug 31, 2026 | SESE |
| [K253555](/device/K253555.md) | Flexitouch® Plus Advanced Pneumatic Compression System | Tactile Medical | Jul 31, 2026 | SESE |
| [K253386](/device/K253386.md) | DVT Garment | Vistar Medical Supplies Co., Ltd. | Jun 25, 2026 | SESE |
| [K250242](/device/K250242.md) | Compression Therapy Device (LGT-2202DVT) | Guangzhou Longest Medical Technology Co., Ltd. | Apr 24, 2026 | SESE |
| [K254267](/device/K254267.md) | NanoPress 760A-BT (760A-BT) | Mego Afek , Ltd. | Feb 24, 2026 | SESE |
| [K250974](/device/K250974.md) | Bio Arterial Deluxe (IC-BAP-DX) | Bio Compression Systems, Inc. | Dec 12, 2025 | SESE |
| [K250190](/device/K250190.md) | Sequential Compression System (SCD600) | Shenzhen Comen Medical Instruments Co.,Ltd | Dec 8, 2025 | SESE |
| [K251466](/device/K251466.md) | 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. | Oct 28, 2025 | SESE |
| [K251446](/device/K251446.md) | PlasmaFlow X Compression Sleeve Device (XPF0001) | Manamed, LLC | Sep 17, 2025 | SESE |
| [K251086](/device/K251086.md) | PnueAira (PNCU-01) | Biotab, LLC | Aug 18, 2025 | SESE |
| [K250817](/device/K250817.md) | Coretech Compression System (Coretech RHB3003) | Vive Health, LLC | Aug 8, 2025 | SESE |
| [K241096](/device/K241096.md) | Venera 608 Deep Vein Thrombosis (DVT) Prevention System | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | Jan 15, 2025 | SESE |
| [K240499](/device/K240499.md) | ARTAIRA Arterial Compression Device (AACD01) | Airos Medical, Inc. | Oct 11, 2024 | SESE |
| [K241746](/device/K241746.md) | 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 | Oct 4, 2024 | SESE |
| [K232640](/device/K232640.md) | Venowave VW5 | Thermabright | Jun 25, 2024 | SESE |
| [K240125](/device/K240125.md) | Therm-X (Home); Therm-X (AT) | Zenith Technical Innovations | Jun 21, 2024 | SESE |
| [K234155](/device/K234155.md) | Nimbl (model PD08-N1) | Tactile Medical | Jun 21, 2024 | SESE |
| [K232270](/device/K232270.md) | DVT Motion Pneumatic Compression Device | Koge Micro Tech Co., Ltd. | Mar 6, 2024 | SESE |
| [K240011](/device/K240011.md) | Lymphedema Compression | Jkh Health Co., Ltd. | Feb 23, 2024 | SESE |

## Top Applicants

- Bio Compression Systems, Inc. — 12 clearances
- Mego Afek AC , Ltd. — 11 clearances
- Hygia Health Services, Inc. — 9 clearances
- Medical Compression Systems (Dbn) , Ltd. — 9 clearances
- Aircast, Inc. — 7 clearances

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**Source:** [https://fda-staging.innolitics.com/productcode/JOW](https://fda-staging.innolitics.com/productcode/JOW)

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