EUREDUC PNEUMATIC DRAINAGE SYSTEM MODEL TP03

K960902 · Eureduc · JOW · Sep 26, 1996 · Cardiovascular

Device Facts

• Record ID: K960902
• Device Name: EUREDUC PNEUMATIC DRAINAGE SYSTEM MODEL TP03
• Applicant: Eureduc
• Product Code: JOW · Cardiovascular
• Decision Date: Sep 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Lymphedema of lower extremities; post surgical or congenital ; Postmastectomy lymphedema ; Dysfunction of the muscle pump ; Pre, post phases of surgery.

Device Story

Pneumatic drainage system; microprocessor-controlled pump in plastic casing; connects to leg boots or arm sleeves; provides intermittent pneumatic compression; used in clinical or home settings; operated by patient or clinician; output is controlled limb compression; aids lymphatic drainage and muscle pump function; benefits include edema reduction and improved circulation.

Clinical Evidence

No clinical data provided; substantial equivalence based on technical characteristics and performance comparisons.

Technological Characteristics

Microprocessor-controlled pneumatic pump; plastic casing; 15-99 mmHg pressure range; 3-compartment sleeve compatibility; 24 Watts power; 30-minute treatment session capability.

Indications for Use

Indicated for patients with lymphedema of lower extremities (post-surgical or congenital), postmastectomy lymphedema, muscle pump dysfunction, and pre/post-surgical phases.

Regulatory Classification

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.

Predicate Devices

• JOBST EXTREMITY PUMP(R) SYSTEM 7500 (K882683)

Submission Summary (Full Text)

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K960902

SEP 26 1996

EUREDUC TP03 510(k) 1996-01-15 Page 11

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

Submitter's name EUREDUC

Submitter's address 35, rue des Broderies 78310 COIGNIERES FRANCE

Phone # [phone] Fax # [phone]

Name of contact person: Mr Didier CAUZOT

Device Trade name: EUREDUC TP03

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 TP03 is comprised of:

a pneumatic unit in a plastic casing with :

- a microprocessor controlled pump;

- a control panel

a range of garments connectable to the unit:

- leg boots;

- arm sleeves;

The EUREDUC TP03 is intended for :

- Lymphedema of lower extremities; post surgical or congenital ;

- Postmastectomy lymphedema ;

- Dysfunction of the muscle pump ;

- Pre, post phases of surgery.

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EUREDUC TP03 510(k) 1996-01-15 Page 12

Compared technical characteristics and performances (from attached labeling)

| DEVICE NAME | JOBST EXTREMITY PUMP (R) | EUREDUC TP03 |
| --- | --- | --- |
| DEVICE 510(k) | K8826 83 | NA |
| PRESSURE RANGE | 30 to 100 mm Hg | 15 to 99 mm Hg |
| TREATMENT CYCLE | 200 s | Up to 37 s |
| TREATMENT SESSION | NA | 30 mn |
| POWER | 15 Watts | 24 Watts |
| SLEEVES: No OF COMPARTMENTS | Up to 3 | Up to 3 |

The EUREDUC TP03 has similar technical characteristics and performances, identical indications and contraindications to the JOBST EXTREMITY PUMP(R).

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