# K171244: Physiotrace

- Pathway: 510(k) (Traditional)
- Applicant: Nimbleheart, Inc.
- Decided: Aug 23, 2017 after 117 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- 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 K962603 (1997). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113045: Bioharness, Zephyr Technology Corporation (2012) Summary page 4.

## Indications for use
The Physiotracetm Smart is a telemetry device intended for physiological monitoring of men and women above 18 years of age at home, workplace, exercise facilities and alternate care settings. The Physiotracetm Smart records single lead ECG data for up to 60 minutes during resting and exercise activities; and transmits it to a server for review by healthcare team. The Physiotracetm Smart is indicated for use as a general patient monitor to provide physiological information as part of an occupational welfare monitoring system, for general research and performance measurement purposes, or where prescribed by a healthcare professional. The Physiotracetm Smart is not indicated for use on critical care patients. The Physiotrace Smart is not indicated for diagnosis of cardiac conditions.

Source page: https://510kreport.com/device/K171244
Methodology: https://510kreport.com/methodology