Probe

Main information

  • Trade name:
  • Probe, stimulator
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Probe, stimulator
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219979
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219979

MICA Medical Pty Ltd - Probe, stimulator

ARTG entry for

Medical Device Included Class IIa

Sponsor

MICA Medical Pty Ltd

Postal Address

26 Monroe Pl,McDowall, QLD, 4053

Australia

ARTG Start Date

7/02/2014

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

Algotec Research and Development Ltd

The Pinnacle

Station Way

Crawley, West Sussex, RH10 1JH

Products

1. Probe, stimulator

Product Type

Single Device Product

Effective date

7/02/2014

GMDN

36957 Probe, stimulator

Intended purpose

PENS therapy Probes are sterile for single use and are used in conjunction with an Algotec PENS therapy

device. A re-usable, non-sterile Intermediate Cable is the interface between the Probe and the Device.

Probes are intended for the transfer of electrical stimulus, generated from the Algotec PENS therapy

device and delivered to peripheral nerves. The stimulation field remains local to the Probe, the stimulation

source, therefore larger areas may require the use of a longer length Probe, two Probes or a repeated

procedure. PENS therapy probes are only intended for use by a trained physician and only in a clinical

setting.

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 05:48:28 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