Orthosis

Main information

  • Trade name:
  • Orthosis, spinal, thoracic,
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Orthosis, spinal, thoracic,
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217061
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217061

Spinealine Pty Ltd - Orthosis, spinal, thoracic, <specify>

ARTG entry for

Medical Device Included Class 1

Sponsor

Spinealine Pty Ltd

Postal Address

97 Ormond Road,ELWOOD, VIC, 3184

Australia

ARTG Start Date

10/11/2013

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

Cole Ingles Consultants

Flat/RM 701 7/5 On Hong Commercial Building

145 Hennessy Road

, Wan Chai,

Hong Kong - SAR of China

Products

1. Orthosis, spinal, thoracic, <specify>

Product Type

Single Device Product

Effective date

10/11/2013

GMDN

41452 Orthosis, spinal, thoracic, <specify>

Intended purpose

The Spinealine is a spinal orthotic that uses your body weight to facilitate your spines alignment through

traction and stretching. Its elevated nodules act to stimulate trigger points and areas of muscle spasm in

your back muscles.

This aims to restore muscles to their natural length and to stimulate a healthier circulation to tight areas.

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 03:30:32 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