EUREDUC PNEUMATIC DRAINAGE SYSTEM

• 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: Cardiovascular
• Reference & Predicate Devices: K882683
• Predicate For: N/A

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.

Summary

{0}------------------------------------------------

K954788

1996-06-15 Page 11 AMENDED 510(k) EUREDUC TP05

Oct. 28, 1996

... / ...

510(k) SUMMARY as required by 807.92 (c) 5-

Submitter's name	EUREDUC
Submitter's address	35, rue des Broderies78310 COIGNIERESFRANCE
	Phone # [phone] Fax # [phone]
Name of contact person:	Mr. Didier CAUZOT
Device Trade name:	EUREDUC TP05
Device common name:	Pneumatic Drainage System
Classification name:	Sleeve Limb Compressible 74JOW CFR Section 870 58 00
Predicate device name:	JOBST EXTREMITY PUMP(R) SYSTEM 7500
Predicate device 510(k):	K882683
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;

The EUREDUC TP05 is intended for:

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

Regulation Number and Section

§ 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).