Summary for ARTG Entry:
Gower Health and Fitness - Shield, bunion
ARTG entry for
Medical Device Included Class 1
Gower Health and Fitness
66 Kildare Street,BENSVILLE, NSW, 2251
ARTG Start Date
Medical Device Class 1
- 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.
Daiya Industry Co Ltd
Minami - Ku, Okayama, 701-0204
1. Shield, bunion
Single Device Product
13565 Shield, bunion
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.
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.
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