# K080545: Actitrainer

- Pathway: 510(k) (Traditional)
- Applicant: Actigraph, LLC
- Decided: Jul 24, 2008 after 148 days
- Product code: ISD (Exerciser, Measuring)
- Device class: 2
- Regulation: 21 CFR 890.5360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K854030 (1986). 4 ancestors in all.
23 later devices descend from it; 5 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040554: Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256, Manufacturing Technology, Inc. (2004) Summary page 1.

## Most influential descendants
- K181077: ActiGraph CentrePoint Insight Watch (2018), 10 descendants of its own
- K140086: Personal Kinetigraph (PKG) System (2014), 9 descendants of its own
- K221282: Empatica Health Monitoring Platform (2022), 7 descendants of its own
- K230457: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (2023), 4 descendants of its own
- K213519: Rune Labs Tremor Transducer System (2022), 4 descendants of its own

## Indications for use
The ActiTrainer is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. The ActiTrainer can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

Source page: https://510kreport.com/device/K080545
Methodology: https://510kreport.com/methodology