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K Number
K013297
Device Name
AIRCAST, MODEL #3011
Manufacturer
MILLENIUM REPROCESSING SERVICES, INC.
Date Cleared
2002-06-14

(254 days)

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

To apply compression to the lower limbs to help prevent deep vein thrombosis in patients at risk.

Device Description

MRSI Compressible Limb Sleeve

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "MRSI Compressible Limb Sleeve." It primarily addresses the regulatory approval of the device and does not contain information about specific acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot fulfill your request for the detailed information as described in your prompt from the provided text. The document focuses on regulatory equivalence to a predicate device rather than performance metrics from a specific study.

§ 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).