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Vasculaire Compression System

by Venous Health Systems, Inc.

510(k) K103113

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK103113 Date2 Feb 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JOW
Device Class
Class II
Regulation
21 CFR Part 870.5800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Vasculaire Compression System is a mobile, intermittent pneumatic compression system intended to provide sequential compression therapy to the lower limb(s) in the clinical setting or home environment. It is indicated for preventing deep vein thrombosis (DVT), enhancing blood circulation, diminishing post-operative pain and swelling, and reducing wound healing time.

The system is used for treatment and assistance in healing stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, and chronic venous insufficiency. It is also indicated for reducing edema. The device is supplied as a mobile system with various models including FLS-0003 and different sleeve sizes. It has received FDA 510(k) clearance with product code JOW and is regulated under 870.5800.

Other devices from Venous Health Systems, Inc.

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Vasculaire Compression System used for?

    The Vasculaire Compression System is used to provide sequential compression therapy to the lower limbs for preventing deep vein thrombosis (DVT), enhancing blood circulation, diminishing post-operative pain and swelling, reducing wound healing time, and treating conditions like stasis dermatitis, venous stasis ulcers, and chronic venous insufficiency.

  • How is the Vasculaire Compression System supplied?

    The system is supplied as a mobile unit with various models including FLS-0003 and different sleeve sizes to accommodate different patient needs and treatment requirements.

  • What is the regulatory status of the Vasculaire Compression System?

    The Vasculaire Compression System has received FDA 510(k) clearance with product code JOW and is regulated under 870.5800, making it substantially equivalent to other devices in its class.

  • Can the Vasculaire Compression System be used in both clinical and home environments?

    Yes, the Vasculaire Compression System is designed as a mobile device that can be used in both clinical settings and home environments, providing flexibility for treatment options.