PowerCube+ Series (PowerCube Body+) +2 more models
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K240706 FDA 510(k)
- FDA Product Code
- JEH FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1760 FDA 510(k)
- Regulation Number
- 868.1760 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PowerCube+ Series comprises a family of plethysmographs designed to measure volume changes in body compartments, including the body and diffusion compartments. These devices assess respiratory mechanics, lung function, and gas exchange parameters during anesthesia and critical care, providing real-time physiological data for clinical monitoring.
The PowerCube+ Series is intended for use in anesthesiology settings, supplied as reusable medical devices. Each unit operates within Class II regulatory classification under FDA and MDR frameworks, with MRI safety considerations noted in specifications. Devices are calibrated and maintained per manufacturer guidelines, requiring proper storage and periodic servicing to ensure accuracy and reliability.
Frequently asked questions
What clinical scenarios or settings is the PowerCube+ Series designed to support during patient monitoring?
The PowerCube+ Series is specifically designed for use in anesthesiology settings to measure volume changes in body and diffusion compartments. It provides real-time physiological data on respiratory mechanics, lung function, and gas exchange parameters, making it ideal for monitoring patients during anesthesia and in critical care environments where precise respiratory assessment is critical.
How is the PowerCube+ Series supplied, and what does this mean for its maintenance and lifespan?
The PowerCube+ Series is supplied as a reusable medical device, meaning it is built for long-term clinical use with regular calibration and maintenance as outlined by the manufacturer. This design ensures durability and accuracy over time, but it requires proper storage, periodic servicing, and adherence to manufacturer guidelines to maintain performance and reliability.
Are there any special considerations for using the PowerCube+ Series in environments with MRI equipment?
Yes, the PowerCube+ Series includes MRI safety considerations in its specifications, indicating that its design accounts for compatibility with MRI environments. However, specific safety protocols or restrictions should be reviewed in the device’s technical documentation or with the manufacturer to ensure proper use alongside MRI systems.
What types of physiological data can clinicians expect to obtain from the PowerCube+ Series, and how does this differ between the Body+ and Diffusion+ models?
The PowerCube+ Series measures volume changes in body compartments (Body+) and diffusion compartments (Diffusion+), providing real-time data on respiratory mechanics and lung function. The Body+ model focuses on overall body compartment changes, while the Diffusion+ model assesses gas exchange parameters, allowing clinicians to monitor both ventilation and diffusion efficiency during anesthesia or critical care.
How does the regulatory classification of the PowerCube+ Series impact its use in clinical practice?
The PowerCube+ Series falls under Class II regulatory classification under both FDA and MDR frameworks, indicating it involves moderate risk and requires compliance with specific manufacturing, labeling, and post-market surveillance standards. This classification ensures rigorous oversight to maintain safety and performance, but it does not restrict its use—clinicians can rely on it for critical monitoring in anesthesiology as intended, provided proper training and adherence to guidelines are followed.
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.
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 | K240706 | Class II | Active |
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Manufacturer
- Manufacturer
- Ganshorn Medizin Electronic Gmbh
Sources (2)
- FDA 510(k) K240706 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026