# K112647: Bestshape Blood Pressure Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Wistron Corporation
- Decided: Nov 22, 2011 after 71 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: 3 generations back to K021239 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051703: Clever TD-3018A Blood Pressure Monitor, Taidoc Technology Corporation (2005) Summary page 1.

## Indications for use
The BestShape system is a system designed to measure blood pressure non-invasively. It is intended for use at home and in clinical settings. The measurement position of the device is the wrist of the subject. This system should be used for the testing on people Over age of 18. The device is not to be used for the diagnosis or screening of hypertension or for testing on newborns

Source page: https://510kreport.com/device/K112647
Methodology: https://510kreport.com/methodology