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Art-Assist Model AA-1000

FDA 510(k)

Class II (US FDA 510(k))

510(k) K942530

by Aci Medical, Inc.

Identifiers

510(k) Number
K942530 FDA 510(k)
FDA Product Code
JOW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.5800 FDA 510(k)
Regulation Number
870.5800 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Art-Assist Model AA-1000 is a compressible limb sleeve designed to prevent the pooling of blood in a limb. It functions by periodically inflating a sleeve around the limb to assist with circulation.

This device is classified as a Class 2 cardiovascular device and received FDA 510(k) clearance. It is regulated under the product code JOW and meets specified electrical safety requirements.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ART-ASSIST MODEL AA-1000 (K942530) — FDA 510 (k) | Innolitics, PDF Table of Contents, K942530 FDA 510 (k) - ART-ASSIST MODEL AA-1000, Aci Medical, Inc. FDA 510 (k) Products (1985-1996), PDF TABLE OF CONTENTS - Archive.org

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Aci Medical, Inc.

Sources (1)

  • FDA 510(k) K942530 24 fields · synced Sep 22, 2026