Device Dossier

Home CPAP unit

Device Dossier for Home CPAP unit (Home CPAP unit, Class IIa, sponsor iJoysBio). ARTG record, intended purpose, GMDN category — compiled by arcimedes.

Intended purpose

This device can improve the quality of sleep for individuals by delivering positive airway pressure. It is intended for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing over 66 lb (30 kg) and can be used in both home and hospital settings.

TGA Public Summary