Physical

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216911
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216911

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Physical therapy electrical stimulation system,

battery-powered

ARTG entry for

Medical Device Included Class IIa

Sponsor

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Postal Address

Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000

Australia

ARTG Start Date

4/11/2013

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

Sky Medical Technology Ltd T/a Firstkind Ltd

Hawk House Peregrine Business Park Gomm

Road

High Wycombe, , HP13 7DL

Products

1. Physical therapy electrical stimulation system, battery-powered

Product Type

Single Device Product

Effective date

4/11/2013

GMDN

46573 Physical therapy electrical stimulation system, battery-powered

Intended purpose

Neuromuscular stimulation devices intended to:

. increase blood circulation

. for the prevention of venous thrombosis

. for the prevention and treatment of oedema

. for promoting wound healing

. for the promotion of healing of tendon and ligament injuries

. for the treatment of venous insufficiency and ischemia

. accelerate the removal of metabolic waste

. speed up leg muscle recovery

. reduce DOMS (delayed onset muscle soreness) within 24 hours following strenuous exercise in healthy

individuals.

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 02.12.2017 at 05:02:07 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

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