Therapeutic

Main information

  • Trade name:
  • Therapeutic diabetic socks
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Therapeutic diabetic socks
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221792
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221792

Perform-Tex Australasia - Therapeutic diabetic socks

ARTG entry for

Medical Device Included Class 1

Sponsor

Perform-Tex Australasia

Postal Address

PO Box 1083,HARTWELL, VIC, 3124

Australia

ARTG Start Date

28/03/2014

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

Hologenix LLC

1112 Montana Avenue

Santa Monica, CA, 90403

United States Of America

Products

1. Therapeutic diabetic socks

Product Type

Single Device Product

Effective date

28/03/2014

GMDN

58132 Therapeutic diabetic socks

Intended purpose

A tubular device typically worn on the feet of a diabetic patient intended to help maintain foot health

through specific construction e.g., non-binding cuff, no/flat seams, moisture control materials, and/or

non-wrinkling materials; the construction combines a special therapeutic feature, the inclusion of Celliant

fibres intended to absorb the body's electromagnetic energy emissions (both heat and infrared) and return

infrared energy back to the body to help increase blood flow, circulation and tissue oxygenation.This

device is sued in the home or at healthcare facilities. This is a reusable device.

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 11:48:52 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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