# K991033: Actiwatch-Score

- Pathway: 510(k) (Traditional)
- Applicant: Mini-Mitter Co., Inc.
- Decided: Jun 23, 1999 after 86 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.
35 later devices descend from it; 3 cite it directly.
0 of 38 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
- K093976: Raisin Personal  Monitor (2010), 12 descendants of its own
- K132764: Motion Watch and Pro-Diary (2014), 10 descendants of its own
- K063872: Kinesia (2007), 10 descendants of its own
- K140086: Personal Kinetigraph (PKG) System (2014), 9 descendants of its own
- K142476: Master Caution Device MCD (2015), 6 descendants of its own

## Indications for use
The Actiwatch-Score® is a compact, lightweight, wrist-worn activity monitor that can be used to analyze circadian rhythms, automatically collect and analyze data for sleep parametefs, and assess activity in any instance where quantifiable analysis of physical motion is desirable. In addition, the Actiwatch-Score® has a built-in score pad that allows the subject to subjectively assign and enter a score from 0 to 9. The score pad can be used as a substitute or in addition to the traditional patient diary used in conjunction with activity monitoring.

Source page: https://510kreport.com/device/K991033
Methodology: https://510kreport.com/methodology