# K110770: Healthtracker

- Pathway: 510(k) (Traditional)
- Applicant: Wistron Corporation
- Decided: Nov 16, 2011 after 243 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: 2 generations back to K001907 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070941: Clever Chek Health Care System Software, Version 1.0, Taidoc Technology Corporation (2007) Summary page 1.

## Indications for use
The HealthTracker is a software accessory for use with a blood pressure monitor with data transmission capabilities. This software is able to transfer data from the device's memory to a computer. The HealthTracker is intended for use at home and clinical settings as an aid for users and their healthcare professionals to review, analyze and manage the historical results. The HealthTracker is intended for use with BestShape Blood Pressure Monitoring System.

Source page: https://510kreport.com/device/K110770
Methodology: https://510kreport.com/methodology