ActiGraph LEAP

GUDID 00853048008053

The ActiGraph LEAP™ is a small, worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. The ActiGraph LEAP™ can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

ACTIGRAPH L.L.C.

Kinesiology ambulatory recorder

• Primary Device ID: 00853048008053
• NIH Device Record Key: 623ee0e4-d2c9-4de3-afc5-4ae0f1f02232
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ActiGraph
• Version Model Number: LEAP
• Catalog Number: LEAP
• 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	00853048008053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231532

FDA Product Code

• LEL: Device, Sleep Assessment

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-02
• Device Publish Date: 2024-04-24

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