ActiGraph CPW01

GUDID 00853048008039

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.

ACTIGRAPH L.L.C.

Kinesiology ambulatory recorder

• Primary Device ID: 00853048008039
• NIH Device Record Key: a67865f4-c13d-40ee-94cc-d2c6415b2df5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ActiGraph
• Version Model Number: CentrePoint Insight Watch
• Catalog Number: CPW01
• Company DUNS: 144830952
• Company Name: ACTIGRAPH L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853048008039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181077

FDA Product Code

• LEL: Device, Sleep Assessment

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-05
• Device Publish Date: 2018-10-16

On-Brand Devices [ActiGraph]

• 00853048008039: The ActiGraph CentrePoint Insight Watch is a compact, battery-operated wearable activity recordi
• 00853048008022: The CentrePoint Data Hub is a home-based communication gateway that securely transmits data capt
• 00853048008015: The GT9X is a body worn device that measures and records physical movement associated with daily
• 00853048008008: The wGT3X-BT is a body worn device that measures and records physical movement associated with d
• 00853048008053: The ActiGraph LEAP™ is a small, worn activity monitor designed for documenting physical moveme