# K123539: Stayhealthy Health Kiosk, Stayhealthy Healthcenter Kiosk

- Pathway: 510(k) (Traditional)
- Applicant: Stayhealthy, Inc.
- Decided: Apr 22, 2013 after 157 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K152107: HealthChek Network Health Station (2016), 0 descendants of its own
- K140360: Health Kiosk (2015), 0 descendants of its own

## Indications for use
The Stayhealthy SH-650 is intended to be used by the general public so that the user can measure his/bet own blood pressure, heart rate, percent lean body mass, percent body fat, percent total body water, body weight, and if the user may have color blindness. It is not a diagnostic device and only ifurnishes data so that users can consult their personal physicians or other healthcare professional. The user can also choose to print the data or send the data to a personal physician or a healthcare professional.

Source page: https://510kreport.com/device/K123539
Methodology: https://510kreport.com/methodology