# K132764: Motion Watch and Pro-Diary

- Pathway: 510(k) (Traditional)
- Applicant: Camntech, Ltd.
- Decided: Jan 21, 2014 after 139 days
- Product code: LEL (Device, Sleep Assessment)
- Device class: 2
- Regulation: 21 CFR 882.5050
- 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.
10 later devices descend from it; 4 cite 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)
- K983533: Actiwatch, Mini-Mitter Co., Inc. (1999) Summary page 1.
- K991033: Actiwatch-Score, Mini-Mitter Co., Inc. (1999) Summary page 1.

## Most influential descendants
- K142476: Master Caution Device MCD (2015), 6 descendants of its own
- K161431: SimplECG (2016), 5 descendants of its own
- K201669: SimpleSENSE (2020), 3 descendants of its own
- K212160: SimpleSENSE Platform (2021), 1 descendant of its own
- K243981: Hexoskin Medical System (7100-00016) (2025), 0 descendants of its own

## Indications for use
The MotionWatch and PRO-Diary are compact, lightweight, body-worn activity monitoring devices that may be used to document physical movement associated with applications in physiological monitoring. The devices are intended to monitor limb or body movements during daily living and sleep. The MotionWatch and PRO-Diary can be used to assess activity in any instance where quantifiable analysis of physical motion is desired. Additionally, the PRO-Diary has a built-in score pad that allows the wearer to subjectively assign and enter responses to pre-programmed questions. The score pad can be used as a substitute or in addition to the traditional written patient diary in conjunction with activity monitoring.

Source page: https://510kreport.com/device/K132764
Methodology: https://510kreport.com/methodology