Stimulator

Main information

  • Trade name:
  • Stimulator, electrical, analgesic, peripheral nerve, transcutaneous
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Stimulator, electrical, analgesic, peripheral nerve, transcutaneous
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221855
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221855

Kogan Australia Pty Ltd - Stimulator, electrical, analgesic, peripheral nerve, transcutaneous

ARTG entry for

Medical Device Included Class IIa

Sponsor

Kogan Australia Pty Ltd

Postal Address

139 Gladstone St,South Melbourne, VIC, 3205

Australia

ARTG Start Date

1/04/2014

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

Famidoc Technology Co Ltd

No 212 Yilong Road Hexi Industrial Zone

Jinxia Changan Town Dongguan, Guangdong

Province, 523853

China

Products

1. Stimulator, electrical, analgesic, peripheral nerve, transcutaneous

Product Type

Single Device Product

Effective date

1/04/2014

GMDN

35372 Analgesic TENS system

Intended purpose

The TENS & EMS Stimulator is a battery operated pulse generator that sends electrical impulses to the

body in order to reach the nerves and underlying muscle group. The device consists of an external

stimulator and electrodes placed on the skin. The device is intended to improve blood circulation and is to

be used for pain relief, muscle stimulation and massage. The device provides two controllable output

channels, each output channel has parameters controlled by buttons. The intensity level is adjustable

according to the needs of patients.

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 09.11.2017 at 11:34:50 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