# K992410: Actitrac

- Pathway: 510(k) (Traditional)
- Applicant: Individual Monitoring Systems, Inc.
- Decided: Oct 15, 1999 after 87 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: 2 generations back to K854030 (1986). 2 ancestors in all.
73 later devices descend from it; 5 cite it directly.
0 of 76 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.

## Most influential descendants
- K071641: Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) (2007), 40 descendants of its own
- K071655: Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538 (2007), 30 descendants of its own
- K082475: Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor, Model 9528 (2008), 28 descendants of its own
- K040554: Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256 (2004), 27 descendants of its own
- K103764: Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac Monitor, Model 9528 (2011), 26 descendants of its own

## Indications for use
The ActiTrac is a small wrist-worn activity monitor designed for documenting physical movements associated with applications in physiological monitoring. The device is intended to be used to analyze circadian rhythms, automatically collect and score data for sleep parameters. These parameters, representing the number and intensity of limb movements, are directly correlated to sleep efficiency. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable.

Source page: https://510kreport.com/device/K992410
Methodology: https://510kreport.com/methodology