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The Actical is a compact, lightweight, waist-, wrist-, or ankle-worn activity monitor that may be used to assess human gross motor activity, caloric expenditure, and estimates of energy expenditure based on motor activity in any instance where quantifiable analysis of physical motion is desirable.

The subject device can be classified as physiological signal conditioner as described in 21 CFR 882.1845. Actical is a physiological data recorder consisting of a data recorder which can be worn on the waist (hip), wrist, or ankle of the subject and that detects, measures, and records physical Activity data. A Reader is used to transfer the recorded rata to a Personal Computer (PC) running the Actical Host software. The host software is used to configure the data recorder for data collection, to retrieve logged data from the recorder, to display data and trend graphs, and to provide a means to store the logged data in a PC for later use.

The VitalSense XHR can be used in any setting where physiological body core temperature, skin temperature, or heart rate are used to further the understanding of body function or where quantifiable analysis of temperature or heart rate data is desirable.

The subject device can be classified as physiological signal conditioner as described in 21 CFR 882.1845. VitalSense XHR is a physiological data recorder that is worn on the body. Up to ten sensor inputs may be used with a single VitalSense XHR recorder. The device senses and records physiological data and displays the data on its LCD screen. Recorded data may be transferred later to a PC for display and conversion for export to other programs.

The Actiheart is an ambulatory Heart Rate and Activity Recorder. Actiheart may be used to quantifiably measure Heart Rate, Activity, and estimates of Caloric Expenditure. This device is not intended for use as an ECG monitor.

Actiheart is a compact, ambulatory, physiological Heart Rate and Activity data recorder. Actiheart may be attached to the chest surface through the use of standard ECG electrodes. Recorded data may be transferred later to a PC for display and conversion for export to other programs.

The Mini-Logger® Series 2000 (hereafter referred to as Mini-Logger) is a compact, lightweight, physiological data logger for monitoring heart rate, interbeat-interval (IBI), temperature, ambient light, and activity. The Mini-Logger® can be used in behavioral and circadian rhythm studies, sleep research, occupational health and sports medicine research, and obesity/weight loss studies. The device can be used for any assement of human heart rate or IBI, temperature, and activity that requires logging of data over time and an integrated analysis of the forementioned parameters. The Mini-Logger® may be used in any instance where quantifiable analysis of physiological data is desirable.

The Mini-Logger® Series 2000 is a compact physiological data logger whose physical size and appearance are similar to a small TV remote control. The Mini-Logger® is powered from two replaceable, non-rechargeable lithium cells. The Mini-Logger® is generally worn in the shirt pocket or on a belt using its optional soft pouch. Direct-wired probes used to sense the physiological data are plugged into one or more of the four available data input channels. The device acquires and logs digital data and resistances whose values represent the amplitudes of physiological signals. The physiological signals are temperature, heart inter-beat-interval (IBI), counts representing gross motor activity, and resistance representing ambient light intensity.