Device
Samsung Health Monitor ECG App for Wear OS
Manufacturer
Samsung Electronics Co., Ltd.
Samsung Electronics Co., Ltd.
Model: v1.1
DI: 08806092938823
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2021-08-25
Current Version: 2026-05-07
Description
Samsung Health Monitor ECG App for Wear OS
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1e8ccd97-30d0-4247-a06e-c0931147571a
Distribution Status:
In Commercial Distribution
DUNS Number:
687967554
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08806092938823
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 64275
Name: Patient general health self-management software
Definition:
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.
FDA Product Codes
QDA
Electrocardiograph Software For Over-The-Counter Use
Premarket Submissions
Submission Number:
K201168
Supplement Number:
000