Bed

Main information

  • Trade name:
  • Bed, general-purpose, electrical
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Bed, general-purpose, electrical
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216681
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216681

Hill-Rom Pty Ltd - Bed, general-purpose, electrical

ARTG entry for

Medical Device Included Class IIa

Sponsor

Hill-Rom Pty Ltd

Postal Address

PO Box 6637,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

29/10/2013

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

Hill-Rom Inc

1069 State Route 46 East

Batesville, IN, 47006

United States Of America

Products

1. Bed, general-purpose, electrical

Product Type

Single Device Product

Effective date

29/10/2013

GMDN

34870 Bed, general-purpose, electrical

Intended purpose

The Progessa Bed is intended to be used to treat or prevent pulmonary or other complications associated

with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be

derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy. The Progressa

Bed is intended to provide a patient support to be used in health care environments. The Progressa Bed

may be used in a variety of settings including, but not limited to, acute care, including critical care, step

down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU),

and sections of the emergency department department (ED). The Progressa Bed is capable of being used

with a broad patient population as determined appropriate by the caregiver or institution.

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 04:32:17 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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FDA - U.S. Food and Drug Administration

3-3-2011

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Europe -DG Health and Food Safety

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Europe -DG Health and Food Safety

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Europe -DG Health and Food Safety

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Europe - EMA - European Medicines Agency

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FDA - U.S. Food and Drug Administration

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FDA - U.S. Food and Drug Administration

5-6-2018

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FDA - U.S. Food and Drug Administration