Veinoplus

Main information

  • Trade name:
  • Veinoplus - Physical therapy electrical stimulation system, battery-powered
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Veinoplus - Physical therapy electrical stimulation system, battery-powered
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221035
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221035

Getz Healthcare Pty Ltd - Veinoplus - Physical therapy electrical stimulation system, battery-powered

ARTG entry for

Medical Device Included Class IIa

Sponsor

Getz Healthcare Pty Ltd

Postal Address

5 Orion Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

12/03/2014

Product category

Medical Device Class IIa

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Ad Rem Technology

162 rue du Faubourg Saint Honore

Paris, , 75008

France

Products

1. Veinoplus - Physical therapy electrical stimulation system, battery-powered

Product Type

Medical device system

Effective date

12/03/2014

GMDN

46573 Physical therapy electrical stimulation system, battery-powered

Intended purpose

Veinoplus is a peripheral neuromuscular stimulator that activates calf muscle contractions using electrodes

placed on the calf to improve blood circulation in the lower limbs. For venous circulation is it used to

increase venous outflow, reduce venous stasis and clotting (DVT) risk, and to relieve the symptoms of

venous insufficiency, varicose veins, leg pain and heaviness leg pain and swelling. For arterial circulation it

can be used to improve blood flow into the lower limbs

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 02:27:48 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information