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K Number
K991038
Device Name
VASO PRESS DVT SYSTEM, MODELS VP500, VP501
Manufacturer
BRITT CORP., INC.
Date Cleared
2000-06-22

(451 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 Vaso Press system is an external pneumatic compression system intended to lower the risk of deep vein thrombosis (DVT) in patients whom may be at risk

Device Description

Vaso Press DVT System, Pump Model VP 500 and Sleeve Model VP 501

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device. The document is a 510(k) summary and approval letter, which primarily focuses on the regulatory aspects of device clearance rather than the detailed performance testing and validation studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

§ 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).