# K201669: SimpleSENSE

- Pathway: 510(k) (Traditional)
- Applicant: Nanowear, Inc.
- Decided: Nov 6, 2020 after 140 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: 8 generations back to K882803 (1988). 50 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161431: SimplECG, Nanowear, Inc. (2016) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The SimpleSENSE System is intended for use at home, or at a healthcare facility, under the direction of a licensed medical professional, to record, display and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; and d) Activity including posture. The device is intended for use when the clinician decides to evaluate the physiologic signals of adult patients as an aid to diagnosis and treatment. The SimpleSENSE System is intended to be used by patients at rest and not performing any activities or movements. ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances. The device does not produce alarms and is not intended for active patient monitoring (real-time). The device is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The device is not intended for use in the presence of a pacemaker.

Source page: https://510kreport.com/device/K201669
Methodology: https://510kreport.com/methodology