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PAS Anti-Embolism System

by Hamilton Industries, Inc.

510(k) K770956

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 NumberK770956 Date12 Sep 1977ClearedStatusActive

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  • Withdrawn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 PAS Anti-Embolism System is a sleeve, limb, compressible device intended for use as an intermittent limb compression device to assist in the prevention of deep vein thrombosis. It is classified as a Class II medical device under regulation number 870.5800 and was found substantially equivalent through the traditional 510(k) pathway.

The system is supplied as a pair of wraps with air bladders for single patient use only and is designed to be used with a PAS air pump unit. It is manufactured by Hamilton Industries, Inc. and received FDA 510(k) clearance under K770956 on September 12, 1977.

Other devices from Hamilton Industries, 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 PAS Anti-Embolism System intended for?

    The PAS Anti-Embolism System is intended for use as an intermittent limb compression device to assist in the prevention of deep vein thrombosis by providing compressive therapy to the limbs.

  • How is the PAS Anti-Embolism System supplied and is it reusable?

    The system is supplied as a pair of wraps with air bladders and is designated for single patient use only, meaning it should not be reused after use on a patient to maintain safety and effectiveness.

  • What equipment is required to operate the PAS Anti-Embolism System?

    The PAS Anti-Embolism System is designed to be used with a PAS air pump unit, which provides the necessary air pressure to inflate and deflate the bladders in the wraps for intermittent compression therapy.