Chair Sensing Unit for EarlySense System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K133661 FDA 510(k)
- FDA Product Code
- BZQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.2375 FDA 510(k)
- Regulation Number
- 868.2375 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Chair Sensing Unit is a device designed for continuous, contact-less measurement of respiration rate, heart rate, and movement. It is intended for use in home, hospital, or clinic settings, supporting children, adolescents, and adults.
The device is supplied as part of the EarlySense system and is intended for use while the patient is resting. It is a single-use device and is not indicated for use in MRI environments. The device is regulated under FDA 510(k) clearance.
Frequently asked questions
What does the Chair Sensing Unit measure?
It continuously measures respiration rate, heart rate, and movement without physical contact while the patient is resting.
Where can this device be used?
It is intended for use in home, hospital, or clinic environments to support children, adolescents, and adults.
Is the Chair Sensing Unit a single-use device?
Yes, it is supplied as a single-use device and is not indicated for use in MRI environments.
How is the device regulated?
The Chair Sensing Unit is regulated under FDA 510(k) clearance.
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 EarlySense Ltd. EarlySense Chair Sensing Unit Applicant's Name: Contact ..., CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM (K133661) — FDA 510(k ..., EARLYSENSE INSIGHT AME-01350-US USER MANUAL Pdf Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133661 | Class II | Active |
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Manufacturer
- Manufacturer
- Earlysense, Ltd.
Sources (1)
- FDA 510(k) K133661 24 fields · synced Sep 22, 2026