# K113045: Bioharness

- Pathway: 510(k) (Traditional)
- Applicant: Zephyr Technology Corporation
- Decided: Aug 14, 2012 after 306 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: 7 generations back to K962603 (1997). 34 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063044: Cardiobelt Electrode Belt, Monebo Technologies, Inc. (2007) Summary page 1.
- K100040: Bioharness, Zephyr Technology Corporation (2010) Summary page 1.

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

## Indications for use
The RioHarness 3.0 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 ECG, heart rate, respiration rate, body orientation and activity. The Biol-arness 3.0 provides a facility to detect and transmit single lead EGG signals to be received by Bluetooth / USB qualified ECG instruments. The RioHarness 3.0 collects and transmits measurements captured during both sedentary as well as rigorous activity for Heart Rate, Posture and Activity. Breathing rate values are accurately transmitted only during sedentary periods. The RioHarness 3.0 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.

Source page: https://510kreport.com/device/K113045
Methodology: https://510kreport.com/methodology