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K Number
K002287

Validate with FDA (Live)

Device Name
WIZAIR COMPRESSION SYSTEM
Manufacturer
MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD.
Date Cleared
2000-08-25

(29 days)

Product Code
JOW
Regulation Number
870.5800
Type
Special
Panel
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K022340,K041659,K051438,K060146
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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).