Motion Watch And Pro-Diary
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by CamNtech Ltd
Identifiers
- 510(k) Number
- K132764 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 MotionWatch and Pro-Diary is a tri-axial actigraphy device designed for sleep assessment, circadian rhythm monitoring, and physical activity tracking. Classified under product code LEL, it falls within the regulatory category of Sleep Assessment devices and is intended for use in neurology applications.
This device is supplied as a reusable, non-sterile medical instrument and is regulated under FDA 510(k) clearance (K132764) and the Medical Device Regulation (MDR). It is intended for clinical and research settings, with no specific MRI safety classification noted. The device is authorised for use in the United States under the classification of Class II and is governed by regulation number 882.5050.
Frequently asked questions
What clinical applications is the MotionWatch and Pro-Diary primarily used for, and why is it relevant to neurology?
The MotionWatch and Pro-Diary is designed for sleep assessment, circadian rhythm monitoring, and physical activity tracking. Its relevance to neurology stems from its ability to provide objective data on sleep patterns and activity levels, which are critical for diagnosing and managing neurological conditions such as sleep disorders, circadian rhythm disturbances, and other conditions where sleep and activity are key diagnostic factors.
Is the MotionWatch and Pro-Diary intended for single-use or reusable applications, and what does this mean for clinical workflows?
The MotionWatch and Pro-Diary is supplied as a reusable device, meaning it is not designed for single-use. This allows for cost-effective use in clinical and research settings, as the device can be cleaned and reused across multiple patients or studies. However, proper cleaning and maintenance protocols must be followed to ensure accuracy and hygiene, as it is not sterile.
What regulatory pathways does the MotionWatch and Pro-Diary follow, and where is it authorized for use?
The MotionWatch and Pro-Diary is authorized for use in the United States under FDA 510(k) clearance (K132764), classified as Class II. It is also governed by the Medical Device Regulation (MDR) in the EU. The device was determined to be substantially equivalent to a predicate device and falls under product code LEL for sleep assessment devices, with an advisory committee classification in Neurology.
How does the tri-axial design of the MotionWatch and Pro-Diary enhance its functionality compared to single-axis devices?
The tri-axial design of the MotionWatch and Pro-Diary allows it to measure movement in three dimensions (X, Y, and Z axes), providing a more comprehensive and accurate assessment of physical activity, sleep posture, and circadian rhythms. This multi-dimensional tracking improves the reliability of data collected for clinical and research purposes, particularly in distinguishing between different types of movement and sleep patterns.
What storage or handling considerations should be taken into account for the MotionWatch and Pro-Diary?
Since the MotionWatch and Pro-Diary is non-sterile and reusable, it must be stored in a clean, dry environment to prevent contamination and ensure device integrity. Before reuse, it should undergo appropriate cleaning and calibration procedures as outlined in the manufacturer’s instructions to maintain accuracy and hygiene. No specific MRI safety classification is noted, so it should not be used in MRI environments unless confirmed safe by the manufacturer.
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: MotionWatch 8 - CamNtech, MotionWatch and PRO-Diary gain US FDA clearance - CamNtech, MOTION WATCH AND PRO-DIARY (K132764) — FDA 510(k) | Innolitics, MotionWatch 8 - camntech, MOTION WATCH AND PRO-DIARY 510(k) K132764 - FDA.report
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 | K132764 | Class II | Active |
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Manufacturer
- Manufacturer
- CamNtech Ltd
- FDA Applicant
- Camntech, Ltd.
Sources (2)
- FDA 510(k) K132764 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026