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K Number
K071744
Device Name
AVIAFIT PULSATING LEGBAND
Manufacturer
FLOWMEDIC LTD.
Date Cleared
2007-09-25

(90 days)

Product Code
JOW
Regulation Number
870.5800
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
K111720
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Aviafit™ is intended to improve blood circulation in the lower limbs and reduce the risk of deep vein thrombosis, edema and leg discomfort during limited mobility conditions at home, at the office and during mid-long haul flights.

Device Description

AviaFit™ Pulsating Legband

AI/ML Overview

This document is a 510(k) summary for the AviaFit™ Pulsating Legband. It primarily focuses on regulatory approval and does not contain detailed information about acceptance criteria, device performance studies, or the methodologies used to establish ground truth.

Therefore, the requested information cannot be extracted from the provided text. The document confirms the FDA has found the device substantially equivalent to a legally marketed predicate device, but it lacks the specific study details needed to answer the questions about acceptance criteria and performance 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).