ActiGraph LEAP Activity Monitor
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231532 FDA 510(k)
- FDA Product Code
- LEL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5050 FDA 510(k)
- Regulation Number
- 882.5050 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ActiGraph LEAP Activity Monitor is a wearable device designed for sleep assessment and physical activity monitoring. It records continuous, high-resolution acceleration data, which are processed to generate objective metrics of movement and sleep patterns. Classified under FDA product code LEL, it falls within Class II medical devices, regulated for use in neurology-related applications.
The device is intended for single-use deployment, where data is collected via onboard sensors and transmitted to the cloud-based CentrePoint software system for analysis. Supplied as a reusable wearable (with replaceable components as needed), it operates without MRI compatibility constraints. Storage and handling follow standard clinical device protocols, and its regulatory status includes FDA 510(k) clearance and MDR compliance. No sterilisation is required, as it is non-invasive and designed for direct patient wear.
Frequently asked questions
What types of clinical assessments is the ActiGraph LEAP Activity Monitor primarily used for, and how does it collect data?
The ActiGraph LEAP Activity Monitor is designed for sleep assessment and physical activity monitoring, particularly within neurology-related applications. It continuously records high-resolution acceleration data through onboard sensors, which are then processed to generate objective metrics of movement and sleep patterns. The device transmits this data to the cloud-based CentrePoint software system for detailed analysis.
Is the ActiGraph LEAP Activity Monitor intended for single-use or reusable deployment, and what does this mean for maintenance?
The ActiGraph LEAP Activity Monitor is classified as a single-use deployment device, meaning it is intended for one-time patient use. However, it is supplied as a reusable wearable with replaceable components as needed, allowing for cost-effective use across multiple patients. Maintenance primarily involves replacing worn or damaged components rather than sterilization or deep cleaning, as no sterilisation is required.
Does the ActiGraph LEAP Activity Monitor have any MRI compatibility restrictions, and how should it be stored?
The ActiGraph LEAP Activity Monitor operates without MRI compatibility constraints, meaning it can be used in environments where MRI scans are performed without interference. For storage and handling, it follows standard clinical device protocols, ensuring proper care to maintain functionality and data integrity for future use.
What regulatory pathways has the ActiGraph LEAP Activity Monitor undergone, and how does this affect its use in clinical settings?
The ActiGraph LEAP Activity Monitor has undergone FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR). These regulatory pathways confirm its substantial equivalence to a predicate device and ensure it meets safety and performance standards for use in clinical settings, particularly in neurology-related applications. Clinicians can rely on its compliance for reliable sleep and activity monitoring.
How does the ActiGraph LEAP Activity Monitor differ from other activity monitors in terms of its intended use and data transmission?
Unlike some activity monitors that rely on manual data transfer or require additional hardware, the ActiGraph LEAP Activity Monitor automatically transmits its high-resolution acceleration data to the CentrePoint software system via cloud connectivity. This seamless integration streamlines analysis and eliminates the need for manual intervention, making it ideal for continuous, objective monitoring of sleep and physical activity in neurology applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Instructions for Use ActiGraph LEAP - ametris.com, ActiGraph LEAP | Ametris Wearable Devices, ACTIGRAPH LEAP INSTRUCTIONS FOR USE MANUAL Pdf Download
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K231532 | Class II | Active |
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Manufacturer
- Manufacturer
- Actigraph, LLC
Sources (2)
- FDA 510(k) K231532 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026