# K100040: Bioharness

- Pathway: 510(k) (Traditional)
- Applicant: Zephyr Technology Corporation
- Decided: Dec 3, 2010 after 330 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K962603 (1997). 23 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061993: Equivital, Model EQ-01, Hidalgo Limited (2006) Summary page 2.
- K052489: Actiheart, Respironics, Inc. (2005) Summary page 4.
- K043604: Lifeshirt Real-Time with Vivomonitor Software, Vivometrics, Inc. (2005) Summary page 4.
- K030795: Lifesyne Systems, Gmp/Companies, Inc. (2003) Summary page 4.

## Most influential descendants
- K113045: Bioharness (2012), 2 descendants of its own
- K171244: Physiotrace (2017), 0 descendants of its own
- K122763: Physiological Data Processor (2013), 0 descendants of its own

## Indications for use
The BioHarness is a physiological monitoring telemetry device intended for monitoring of adults in the home, workplace and alternate care settings. The device consists of a chest strap and an electronics module that attaches to the strap. The device stores and transmits vital sign data including heart rate, respiration rate, thoracic skin temperature, body orientation and activity. The RioHarness collects and transmits measurements captured during both sedentary as well as rigorous activity for Heart Rate, Skin Temperature, Posture and Activity. Breathing rate values are accurately transmitted only during sedentary periods. The RioHarness is indicated for use as a general patient monitor to provide physiological information as part of an occupational welfare monitoring system, and for general research and performance measurement purposes.

Source page: https://510kreport.com/device/K100040
Methodology: https://510kreport.com/methodology