Static intermittent

Main information

  • Trade name:
  • Static/intermittent powered traction system, non-mobile
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Static/intermittent powered traction system, non-mobile
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217861
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217861

Body and Spine Pty Ltd - Static/intermittent powered traction system, non-mobile

ARTG entry for

Medical Device Included Class IIa

Sponsor

Body and Spine Pty Ltd

Postal Address

1/103 Majors Bay Road,CONCORD, NSW, 2137

Australia

ARTG Start Date

29/11/2013

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

Advanced Back Technologies Inc

89 Cabot Court

Suite F

Hauppauge, New York, 11788

United States Of America

Products

1. Static/intermittent powered traction system, non-mobile

Product Type

Single Device Product

Effective date

29/11/2013

GMDN

45537 Static/intermittent powered traction system, non-mobile

Intended purpose

A multi-functional therapeutic device capable of applying continuous and various intermittent (regular,

progressive/regressive, cycled) traction forces for the treatment of patients suffering from severe low back

pain and sciatica.

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 12:45:24 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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Therapeutic Goods Administration - Australia