← Product Code [JOW](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW) · K960902

# EUREDUC PNEUMATIC DRAINAGE SYSTEM MODEL TP03 (K960902)

_Eureduc · JOW · Sep 26, 1996 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K960902

## Device Facts

- **Applicant:** Eureduc
- **Product Code:** [JOW](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW.md)
- **Decision Date:** Sep 26, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.5800
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** Therapeutic

## Indications for 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.

## Regulatory 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](/device/K882683.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

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 # (33) 1 34 61 01 61 Fax # (33) 1 34 61 40 61

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.

.../...

{1}

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).

.../...

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K960902](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K960902)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com