Shield

Main information

  • Trade name:
  • Shield, bunion
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Shield, bunion
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220101
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220101

Gower Health and Fitness - Shield, bunion

ARTG entry for

Medical Device Included Class 1

Sponsor

Gower Health and Fitness

Postal Address

66 Kildare Street,BENSVILLE, NSW, 2251

Australia

ARTG Start Date

13/02/2014

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

Daiya Industry Co Ltd

1253 Ofuku

Minami - Ku, Okayama, 701-0204

Japan

Products

1. Shield, bunion

Product Type

Single Device Product

Effective date

13/02/2014

GMDN

13565 Shield, bunion

Intended purpose

GMDN: 18029

Pain and deformation are the result of eversion of the big toe (i.e., it is turned outward) and inversion of the

first metatarsal bone (turned inward). While walking, talipes valgus or duck footedness causes the end of

the first metatarsal bone to become inverted. This causes pressure and friction from the shoes and results

in pain. The function of the big toe while walking is to kick off from the step.

The device "Ultrathin Bunion Corrector" is a soft textile product, and a supporter for mild condition of hallux

valgus. Ultrathin Bunion Corrector makes very slight adjustments to the foot, bringing the big toe closer to

the open position. And by encircling the foot from the top and holding it tight, it helps the sole form an arch.

The arch is another important way to bring the big toe into an open position. This supporter twists the big

toe back in the direction of inversion and at the same time, corrects the direction of the first metatarsal

bone. A hole in the tip of the big toe leads to pressure relief for more wearing comfort.

This bunion supporter uses very thin, breathable, elastic in each direction and anti-slip material is used.

Most of bunion supporters tended to be too thick to wear normal shoes. This new material consists of

0.4mm thickness of bonding "Powernet" and non-woven fabric. It is able to prevent the product from

moving over because the non-woven fabric is anti-skid. The fabric is also stretchable with a comfortable fit.

The high breathability makes it possible to wear for a long time. The product is hard to spot due to the

beige colouring, so that a woman can wear with her bare foot and underneath of a stocking. It is also

possible to wear the product with heels and sandals because of the very thin material.

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 05:18:08 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

26-5-2018

Shadow Holdings, LLC Issues Voluntary Nationwide Recall of X-Jow and Acne Shave products due to Possible Bacterial Contamination

Shadow Holdings, LLC Issues Voluntary Nationwide Recall of X-Jow and Acne Shave products due to Possible Bacterial Contamination

Shadow Holdings is voluntarily recalling all lots, within expiry, of Herb-X Solutions X-Jow Pain Gel, and United Exchange Acne Shave Moisturizer, Acne Shave Shave Cream with Acne Shield, and Acne Shave Shave Kit to the retail level. The products may be contaminated with bacteria.

FDA - U.S. Food and Drug Administration

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