EUREDUC PNEUMATIC DRAINAGE SYSTEM

K954788 · Eureduc · JOW · Oct 28, 1996 · Cardiovascular

Device Facts

• Record ID: K954788
• Device Name: EUREDUC PNEUMATIC DRAINAGE SYSTEM
• Applicant: Eureduc
• Product Code: JOW · Cardiovascular
• Decision Date: Oct 28, 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 ; Pre, intra, post phases of surgery.

Device Story

Pneumatic drainage system; metal casing; microprocessor-controlled pump; control panel; connectable garments (leg boots, arm sleeves). Device applies intermittent pneumatic compression to limbs to manage lymphedema. Operated by healthcare professionals in clinical settings. Output consists of controlled pneumatic pressure cycles to reduce edema; aids in lymphatic drainage; improves patient outcomes post-surgery or for congenital conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pneumatic drainage system; metal casing; microprocessor-controlled pump; control panel; limb garments (boots/sleeves). Operates via pneumatic compression. Software-controlled pressure cycles.

Indications for Use

Indicated for patients with lymphedema of lower extremities (post-surgical or congenital) and post-mastectomy lymphedema, including use during pre, intra, and 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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K954788

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

Oct. 28, 1996

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 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.

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