# K062068: Intelwave Heart Rate Variability System, Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Intelwave, LLC
- Decided: Oct 27, 2006 after 98 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922171 (1992). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010955: BMT Anscore Health Management System, Boston Medical Technologies, Inc. (2001) Summary page 1.
- K042463: Holter Plus, Rozinn Electronics, Inc. (2004) Summary page 1.
- K941252: Respiratory and Cardiac Spectral Frequency Signal Processor, Ansar (1995) Summary page 1.
- K021230: HERO, Medical Decision Networks (2003) Summary page 1.

## Most influential descendants
- K142551: QANS (Quantitative Autonomic Nervous System) Monitoring System (2015), 0 descendants of its own

## Indications for use
The Intelwave 1.0 System is intended for use in Heart Rate Variability (HRV) measurements in response to paced respiration and controlled exercises.

Source page: https://510kreport.com/device/K062068
Methodology: https://510kreport.com/methodology