ACTIGRAPH L.L.C.

Address:49 E Chase St,Pensacola,FL,32502,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Exerciser, Measuring (ISD) (2) Device, Sleep Assessment (LEL) (1) Medical Device Data System (OUG) (1)

Premarket Exempt

No Yes

Clear

Actigraph - 00853048008008 Catalog Number :

Device Description : The wGT3X-BT is a body worn device that measures and records physical movement a The wGT3X-BT is a body worn device that measures and records physical movement associated with daily activity and sleep. The wGT3X-BT is intended for use in applications where quantifiable measurement and storage of physical movement is desired.

Device Class : 2

Duns Number: 144830952

Premarket Exempt : No

Product Code : ISD

Prescription Use : Yes

Device Count : 1

ActiGraph - 00853048008015 Catalog Number :

Device Description : The GT9X is a body worn device that measures and records physical movement assoc The GT9X is a body worn device that measures and records physical movement associated with daily activity and sleep. The GT9X is intended for use in applications where quantifiable measurement and storage of physical movement is desired.

Device Class : 2

Duns Number: 144830952

Premarket Exempt : No

Product Code : ISD

Prescription Use : Yes

Device Count : 1

ActiGraph - 00853048008022 Catalog Number :

Device Description : The CentrePoint Data Hub is a home-based communication gateway that securely tra The CentrePoint Data Hub is a home-based communication gateway that securely transmits data captured by ActiGraph activity monitors.

Device Class : 1

Duns Number: 144830952

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

ActiGraph - 00853048008039 Catalog Number : CPW01

Device Description : The ActiGraph CentrePoint Insight Watch is a compact, battery-operated wearable The ActiGraph CentrePoint Insight Watch is a compact, battery-operated wearable activity recording device with physical characteristics similar to those of a small wristwatch. The watch is intended to acquire and store data from an onboard accelerometer while being worn during normal activities and/or during sleep. The data record is timestamped and stored in non-volatile memory for later retrieval. Downloaded data can be post-processed based on the timestamp and magnitude of acceleration along each axis. The housing is constructed of a combination of opaque and clear copolyesters formulated specifically for medical devices (i.e., tested and determined biocompatible), and the core data collection sensor is a 3-axis microelectromechanical system (MEMS) accelerometer. A charging dock connected to a USB power source is used to charge the device battery and communicate with a PC or peripheral.

Device Class : 2

Duns Number: 144830952

Premarket Exempt : No

Product Code : LEL

Prescription Use : Yes

Device Count : 1

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