# K140360: Health Kiosk

- Pathway: 510(k) (Traditional)
- Applicant: Engagementhealth, LLC
- Decided: Apr 10, 2015 after 422 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K910772 (1991). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063137: Pharmasmart Public Use Blood Pressure Monitor, Models PS-1000/PS-1500/PS-2000, Pharmasmart, Inc. (2007) Summary page 5.
- K123539: Stayhealthy Health Kiosk, Stayhealthy Healthcenter Kiosk, Stayhealthy, Inc. (2013) Summary page 5.
- K010828: Digital Blood Pressure Monitors, Models TM-2655, TM-2655P, & TM-2655VP, A&D Engineering, Inc. (2001) Summary page 5.

## Indications for use
The EngagementHealth Kiosk is intended to be used by the general public as a non-invasive multi-functional unit which measures a person’s weight, blood pressure and heart rate. The kiosk is not intended to be a diagnostic device and does not perform any diagnoses. Rather, the kiosk provides the user with weight and systolic/diastolic blood pressure to be used as supplemental data when consulting a professional physician. The EngagementHealth Kiosk is intended to be fully unattended and placed within public or corporate environments. The user can choose to send the data to the EngagementHealth web portal for later data visualization.

Source page: https://510kreport.com/device/K140360
Methodology: https://510kreport.com/methodology