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K Number
K024019
Device Name
ARTERIALFLOW SYSTEM, MODEL 32A
Manufacturer
AIRCAST, INC.
Date Cleared
2003-06-03

(180 days)

Product Code
JOW
Regulation Number
870.5800
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For the improvement of blood circulation in the upper and lower extremities to help prevent and reduce complications of poor circulation.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria, study details, and device performance for the Arterialflow System, Model 32A. The document is an FDA 510(k) clearance letter, which primarily deals with the regulatory approval of the device based on its substantial equivalence to a predicate device. It indicates that the device can be legally marketed but does not provide details about performance studies or acceptance criteria that would typically be found in a clinical trial report or a summary of safety and effectiveness data.

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).