# K161431: SimplECG

- Pathway: 510(k) (Traditional)
- Applicant: Nanowear, Inc.
- Decided: Nov 30, 2016 after 190 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K882803 (1988). 49 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143032: eMotion Faros ECG Mobile, Mega Electronics, Ltd. (2015) Summary page 4.
- K142476: Master Caution Device MCD, Healthwatch, Ltd. (2015) Summary page 4.

## Most influential descendants
- K201669: SimpleSENSE (2020), 3 descendants of its own
- K212160: SimpleSENSE Platform (2021), 1 descendant of its own
- K243981: Hexoskin Medical System (7100-00016) (2025), 0 descendants of its own
- K232053: SimpleSense-BP, SimpleSense-BP Software Application (2023), 0 descendants of its own
- K173248: Cardioskin (2018), 0 descendants of its own

## Indications for use
The SimplECG is intended to aid in the diagnostic evaluation of patients, 21 years of age and above, on the order of a physician, who experience transient symptoms which may suggest the need for monitoring to manually assess their cardiac rhythm disturbance. ECG data is recorded, stored, transferred and displayed wirelessly for review by a physician who is skilled in rhythm interpretation.

Source page: https://510kreport.com/device/K161431
Methodology: https://510kreport.com/methodology