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Healthcare Service and Supply ALP Alternating Leg Pressure Pump and Garments for the Limb

by Healthcare Service and Supply

510(k) K000303

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 NumberK000303 Date16 May 2000ClearedStatusActive

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  • Withdrawn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, 26 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 device is a sleeve, limb, compressible, intended for external compression therapy using the alternating leg pressure system to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism in patients with risk factors for thrombosis formation. It consists of a pump and garments designed for limb application.

It is supplied as a system comprising a pump and garments, with FDA 510(k) clearance under K000303. The device is classified as Class II, regulated under regulation number 870.5800, and is indicated for use in clinical settings where external compression therapy is required.

Other devices from Healthcare Service and Supply

Questions

AI-generated answers, 26 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 Healthcare Service and Supply ALP Alternating Leg Pressure Pump and Garments used for?

    The device is intended for external compression therapy using an alternating leg pressure system to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism in patients with risk factors for thrombosis formation. It is used in clinical settings where external compression therapy is required.

  • How is the Healthcare Service and Supply ALP device supplied and what does it include?

    The device is supplied as a system comprising a pump and garments designed for limb application. It is not sold as separate components but as a combined unit for external compression therapy.

  • Is the Healthcare Service and Supply ALP device sterile or single-use?

    The device data does not specify whether the garments or pump are sterile or single-use. It is described as a reusable system intended for clinical use, but no explicit statements about sterility or single-use status are provided in the source information.

  • What regulatory pathway was used for the Healthcare Service and Supply ALP device?

    The device received FDA 510(k) clearance under submission number K000303, indicating it was found substantially equivalent to a legally marketed predicate device. It is classified as Class II under regulation number 870.5800.