Samsung Sleep Apnea Feature (Android OS)

Basic Information

• Brand Name: Samsung Sleep Apnea Feature (Android OS)
• Primary DI: 08806094936889
• Version / Model: 1.X
• Company Name: Samsung Electronics Co., Ltd.
• Labeler DUNS: 687967554
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-24
• Public Version: 2
• Public Version Date: 2025-07-08
• Public Version Status: Update
• Public Device Record Key: 62fa6d67-cedf-4096-ba63-81a8aef38d9c

Device Description

The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QZW	Over-The-Counter Device To Assess Risk Of Sleep Apnea	Anesthesiology	868.2378	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64275	Patient general health self-management software	An Internet-based software program intended to be used on a non-medical computerized device, by a patient in a non-clinical environment, to provide general health assessment information and/or health advice through an interactive platform; it is not dedicated to a specific condition. The software is intended to collect patient information (demographics, lifestyle data, and/or symptoms) and feedback information to indicate the general health/wellness in key areas (e.g., mental, cardiovascular) and/or assist the patient in deciding the best course of action if they are unwell (e.g., see a clinician, self-treatment for minor ailments). It does not communicate with a clinician.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08806094936889	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN230041	000