FDA 510(k) · Samsung
K132148: S HEALTH (Samsung Electronics Co., Ltd.)
Samsung Electronics Co., Ltd. received FDA 510(k) K132148 for S HEALTH, with a decision date of Dec 4, 2013 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K132148 |
|---|---|
| Pathway | 510(k) |
| Applicant | Samsung Electronics Co., Ltd. |
| Device name | S HEALTH |
| Product code | DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Regulation (21 CFR) | 870.2910 |
| Device class | Class 2 |
| Date received | Jul 11, 2013 |
| Decision date | Dec 4, 2013 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
Page 1 of I 5 10(k) Number: K ____________ Device Name: S Health Indication 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). Prescription Use____ (Part 2I1CFR801 Subpart D) AND/OR Over-The-Counter Use V (Part 21ICFR807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 ofll
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DRG is "Transmitters And Receivers, Physiological Signal, Radiofrequency", class 2, 21 CFR 870.2910.
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Unknown. These are heuristics, not FDA fields.