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:
  • 216902
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216902

Pain Management Devices Pty Ltd - Stimulator, electrical, analgesic, peripheral nerve, transcutaneous

ARTG entry for

Medical Device Included Class IIa

Sponsor

Pain Management Devices Pty Ltd

Postal Address

PO Box 4564,MYAREE, WA, 6154

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

Hong Qiangxing Shen Zhen Electronics Limited 4F Jingcheng Building Xicheng Industrial Zone

Xixiang Road Baoan District

Shenzhen, Guangdong Prov, 518126

China

Products

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

Product Type

Single Device Product

Effective date

4/11/2013

GMDN

35372 Analgesic TENS system

Intended purpose

An analgesic peripheral nerve stimulator consisting of an external stimulator and electrode placed on the

skin not penetrating the body at any time, so the electrical stimulus is applied through the skin

(transcutaneously) to the painful area. It typically includes five predetermined stimulation modulation

options, e.g. pulse frequency or pulse duration. It is portable and can be carried in a pocket. This device is

also known as a transcutaneous electric nerve stimulator (TENS) and is used to treat pain associated with

surgery, trauma, musculoskeletal problems, bursitis or dental problems. It is also used in physical therapy

and during labour/delivery.

Specific Conditions

No Specific Conditions included on Record

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Public Summary

Page 1 of

Produced at 10.11.2017 at 03:58:19 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