# K132148: S Health

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Dec 4, 2013 after 146 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K864318 (1987). 81 ancestors in all.
No later device cites it as a predicate yet.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083862: Medapps 2.0 Remote Patient Monitoring System, Medapps, Inc. (2009) Summary page 2.
- K130676: Ambio Remote Health Monitoring System, Arrayent Health, LLC D/B/A Ambio Health (2013) Summary page 2.
- K122098: Apps-HEALTH01, Andon Health Co, Ltd. (2013) Summary page 2.
- K130535: Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Agamatrix, Inc. (2013) Summary page 2.

## Indications for use
The SHealth is a mobile application intended for use in home to help people in reviewing and monitoring vital signs such as non-invasive blood pressure, blood glucose, weight and other data from optional add-an devices for effective health management. The user also can share the data via sharing functions (Email and SMS).

Source page: https://510kreport.com/device/K132148
Methodology: https://510kreport.com/methodology