Disability

Main information

  • Trade name:
  • Disability vehicle, scooter, foot-propelled
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Disability vehicle, scooter, foot-propelled
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220515
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220515

Verseo Distribution Pty Ltd ATF The Verseo Trust - Disability vehicle, scooter, foot-propelled

ARTG entry for

Medical Device Included Class 1

Sponsor

Verseo Distribution Pty Ltd ATF The Verseo Trust

Postal Address

PO Box 2844,BUNDABERG, QLD, 4670

Australia

ARTG Start Date

26/02/2014

Product category

Medical Device Class 1

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

Northrup Medical Supply LLC T/a Knee Walker

Central

228 Park Avenue South 41071

, NY, 10003

United States Of America

Products

1. Disability vehicle, scooter, foot-propelled

Product Type

Single Device Product

Effective date

26/02/2014

GMDN

31144 Disability vehicle, scooter, foot-propelled

Intended purpose

A mobility aid used to provide a physically disabled user with a means of transportation, typically without

attendance from another person. The device consists of a knee and lower leg support with wheels and a

steering handle, and is designed to be used and operated by a disabled person who propells it by pushing

it with one foot. This device will enhance the user's independence to convey themselves from one place to

another within the limitations of the devices construction. Users are anticipated to be adults with injury or

disability limited to the lower area of one leg. The device is re-usable.

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 03:53:15 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

28-9-2018

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

Pfizer Canada has advised Health Canada that, in a very small number of cases, some EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) auto-injector devices may not slide out of their carrier tube easily, or at all. This could delay or prevent emergency treatment, possibly leading to patient disability or death.

Health Canada

There are no news related to this product.