Electrode, transcutaneous, electrical nerve stimulation

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Nurokor Distribution Australia
Class:
Class 1
Authorization status:
Included
Authorization number:
322088

Public Summary

Summary for ARTG Entry:

322088

Nurokor Distribution Australia - Electrode, transcutaneous, electrical nerve stimulation

ARTG entry for

Medical Device Included Class 1

Sponsor

Nurokor Distribution Australia

Postal Address

Suite 46 30 Denison Street,Bondi Junction, NSW, 2022

Australia

ARTG Start Date

21/08/2019

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

JKH Health Co Ltd

4-5F Building 12 Hengmingzhu lndustrial Park

Xinqiao Tongfuyu lndustrial Area

Shajing Bao'an District Shenzhen City,

Guangdong Province, 518104

China

Products

1. Electrode, transcutaneous, electrical nerve stimulation

Product Type

Single Device Product

Effective date

21/08/2019

GMDN

35995 Electrode, transcutaneous, electrical nerve stimulation

Intended purpose

Electrical conductor that is intended to be placed in contact with the patient's skin to transmit an electrical

stimulus.

Specific Conditions

© 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 02.11.2019 at 06:24:37 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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