Hand-held

Main information

  • Trade name:
  • Hand-held deep-tissue electromagnetic stimulator
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Hand-held deep-tissue electromagnetic stimulator
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217500
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217500

Freedom Health Products - Hand-held deep-tissue electromagnetic stimulator

ARTG entry for

Medical Device Included Class IIa

Sponsor

Freedom Health Products

Postal Address

3 East Street,MAYLANDS, WA, 6051

Australia

ARTG Start Date

19/11/2013

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

Natures Naturals Ltd

Ringstead Business Centre 1-3 Spencer Street

Ringstead Ringstead Kettering

, , NN144BX

Products

1. Hand-held deep-tissue electromagnetic stimulator

Product Type

Single Device Product

Effective date

19/11/2013

GMDN

35169 Hand-held deep-tissue electromagnetic stimulator

Intended purpose

A battery-powered, hand-held device designed to apply an electromagnetic (EM) field to body deep tissues

to help reduce pain associated with musculoskeletal/neurological disorders (e.g., arthritis, sciatica) and/or

to treat soft-tissue wounds and injuries. It is a self-contained electronic unit with controls intended to be

applied to the body to emit short-time pulsed, radio-frequency energy [pulsed electromagnetic fields

(PEMF)] to tissues at a level below the patient's heat sensory perception threshold. The device is intended

to be used in clinical and home settings.

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 02:09:25 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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