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K Number
K170415
Device Name
Medline Hemo-Force DVT Compression Sleeve
Manufacturer
Medline Industries, Inc.
Date Cleared
2017-09-08

(210 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

The Medline Hemo-Force DVT compression sleeve is recommended for use in patients for whom external compression therapy is indicated to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding the Medline Hemo-Force DVT Compression Sleeve. It asserts substantial equivalence to predicate devices but does not contain detailed information about acceptance criteria or specific study results that prove the device meets acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence, not on a detailed performance study with acceptance criteria.

§ 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).