Mandible-repositioning antisnoring orthosis

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
01-11-2019

Dostopno od:

Sleep Sound Pty Ltd

Razred:

Class I

Izdeluje:

Sleep Sound Pty Ltd Suite 2 71 Kooyong Road, Caulfield North, VIC, 3161 Australia

Terapevtsko območje:

47526 - Mandible-repositioning antisnoring orthosis

Terapevtske indikacije:

A removable intraoral device designed to prevent snoring and/or obstructive sleep apnoea by repositioning the lower jaw (mandible), frequently in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. The device is typically made of soft and/or hard materials (e.g., plastics and metals); it may or may not be available [non-prescription] over-the-counter (OTC). A number of different fixed (non-adjustable) and adjustable types using several techniques are available. This is a reusable device.

Status dovoljenje:

A

Datum dovoljenje:

2019-09-10

Opozorila o iskanju, povezana s tem izdelkom