Inspire Inspire® Upper Airway Stimulation System - HSA Registration DE0510222
Access comprehensive regulatory information for Inspire Inspire® Upper Airway Stimulation System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0510222 and owned by Inspire Medical Systems, Inc. The device was registered on January 08, 2025.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Inspire® Upper Airway Stimulation (UAS) is used to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA) (apnea-hypopnea index [AHI] of 15≤AHI≤100). Inspire UAS is used in adult patients 22 years of age and older who have been confirmed to fail or cannot tolerate positive airway pressure (PAP) treatments (such as continuous positive airway pressure [CPAP] or bi-level positive airway pressure [BPAP] machines) and who do not have a complete concentric collapse at the soft palate level. Inspire UAS is also indicated for OSA patients ages 18 to 21 years with moderate to severe OSA (15≤AHI≤100), and pediatric patients ages 13 to 18 years with Down syndrome and severe sleep apnea (10≤AHI≤50) who: Do not have complete concentric collapse at the soft palate level, Are contraindicated for, or not effectively treated by, adenotonsillectomy, Have been confirmed to fail, or cannot tolerate, PAP therapy despite attempts to improve compliance.