Mandible-repositioning

Main information

  • Trade name:
  • Mandible-repositioning antisnoring orthosis
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Mandible-repositioning antisnoring orthosis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217259
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217259

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Mandible-repositioning antisnoring orthosis

ARTG entry for

Medical Device Included Class 1

Sponsor

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Postal Address

Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000

Australia

ARTG Start Date

13/11/2013

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

Airway Management

3418 Midcourt #114

Carrollton, TX, 75006

United States Of America

Products

1. Mandible-repositioning antisnoring orthosis

Product Type

Single Device Product

Effective date

13/11/2013

GMDN

47526 Mandible-repositioning antisnoring orthosis

Intended purpose

The myTAP™ is a precision-fit oral device intended to reduce or alleviate nighttime snoring and mild to

moderate obstructive sleep apnea (OSA). The myTAP™ device consists of an Upper Tray that fits on the

upper teeth and Lower Tray that fits on the lower teeth. An Adjustment Mechanism attached to the lower

tray fits into an Adjustment Post on the upper tray. The device holds the lower jaw forward, preventing the

soft tissue of the throat from collapsing and obstructing the airway.

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 02.12.2017 at 04:58:51 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