Skip to content

Wlp Sequential Version Model Wlp Solo VI, Wlp Solo Sequential

by Wright Linear Pump, Inc.

510(k) K961292

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 NumberK961292 Date6 Nov 1996ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

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

The WLP Sequential Version Model WLP Solo VI, WLP Solo Sequential is an electromechanical pneumatic sequential compression pump designed to treat fluid accumulation in extremities. It consists of a compressor, precision timer, regulator, and pressure gage, and connects to a limb sleeve to deliver controlled, sequential compression.

The device is intended for use in hospitals, clinics, or homes. It is supplied with a limb sleeve and operates as a single-patient-use system. The device is not evaluated for MRI safety, and storage conditions should follow standard medical equipment guidelines. It is regulated under FDA product code JOW and was cleared via the 510(k) premarket notification pathway.

Other devices from Wright Linear Pump, Inc.

Questions

AI-generated answers, 1 Oct 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 WLP Solo VI used for?

    It is an electromechanical pneumatic pump designed to treat fluid accumulation in extremities by delivering controlled, sequential compression through a connected limb sleeve. It is intended for use in hospitals, clinics, or home settings.

  • How is the device supplied?

    The device is supplied with a limb sleeve and operates as a single-patient-use system. It includes a compressor, precision timer, regulator, and pressure gage as core components.

  • Is the device reusable?

    No, it is designed as a single-patient-use system. Reuse is not supported due to its configuration and intended use protocol.

  • Where should the device be stored?

    Storage conditions should follow standard medical equipment guidelines. The device is not evaluated for MRI safety, so it should be stored away from MRI environments.

  • What regulatory pathway was used?

    The device was cleared through the FDA 510(k) premarket notification pathway under product code JOW. It was determined to be substantially equivalent to existing devices.