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K Number
K954788
Device Name
EUREDUC PNEUMATIC DRAINAGE SYSTEM
Manufacturer
EUREDUC
Date Cleared
1996-10-28

(376 days)

Product Code
JOW
Regulation Number
870.5800
Type
Traditional
Panel
CV
Reference & Predicate Devices
K882683
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The EUREDUC TP05 is intended for:

  • Lymphedema of lower extremities; post surgical or congenital;
  • Postmastectomy lymphedema ;
  • Pre, intra, post phases of surgery.
Device Description

EUREDUC TP05 is comprised of: a pneumatic unit in a metal casing with - a microprocessor controlled pump; - a control panel - a range of garments connectable to the unit: - leg boots; - arm sleeves;

AI/ML Overview

The provided text for K954788, "EUREDUC TP05," is a 510(k) summary for a "Pneumatic Drainage System." This document primarily describes the device, its intended use, and identifies a predicate device.

Crucially, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.

Therefore, I cannot populate the table or answer the specific questions about device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. This type of detailed performance data is typically found in the main body of a 510(k) submission, not necessarily in the brief 510(k) summary.

§ 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).