# K040554: Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256

- Pathway: 510(k) (Abbreviated)
- Applicant: Manufacturing Technology, Inc.
- Decided: Jul 16, 2004 after 136 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- 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 K854030 (1986). 3 ancestors in all.
27 later devices descend from it; 3 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983533: Actiwatch, Mini-Mitter Co., Inc. (1999) Summary page 1.
- K992410: Actitrac, Individual Monitoring Systems, Inc. (1999) Summary page 1.

## Most influential descendants
- K080545: Actitrainer (2008), 23 descendants of its own
- 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

## Indications for use
The Actigraph is a small, limb-worn activity monitor, typically placed on the wrist or ankle, designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor limb activity associated with movement during sleep. The Actigraph can be used to assess activity in any instance where quantifiable analysis of physical motion is desirable.

Source page: https://510kreport.com/device/K040554
Methodology: https://510kreport.com/methodology