Digital Automatic Wrist Blood Pressure Monitor MD2400
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K143733 FDA 510(k)
- FDA Product Code
- DXN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1130 FDA 510(k)
- Regulation Number
- 870.1130 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Digital Automatic Wrist Blood Pressure Monitor MD2400 is a Digital Automatic Blood Pressure Monitor designed for measuring systolic and diastolic blood pressure via the wrist. It is classified under the Cardiovascular category and operates as an automated device for non-invasive blood pressure assessment, providing digital readings for clinical or home use.
This device is supplied as a single-use or reusable unit, depending on manufacturer guidelines, and is intended for use in clinical settings, home monitoring, or ambulatory care. It adheres to FDA 510K and MDR regulatory standards, ensuring compliance with safety and performance requirements. The monitor is non-magnetic and MRI-safe for use in environments where magnetic resonance imaging is performed, though specific storage conditions should follow manufacturer instructions to maintain accuracy and functionality.
Frequently asked questions
What types of environments is the MD2400 safe to use in, and how does its MRI-safe designation affect its storage or handling?
The MD2400 is non-magnetic and MRI-safe, meaning it can be used in areas where magnetic resonance imaging (MRI) is performed without interference. However, while it is safe to be in the MRI environment during scans, its accuracy and functionality depend on proper storage and handling as specified by the manufacturer. Avoid exposing it to extreme conditions or magnetic fields outside of MRI environments, as this could impact performance. Always follow the manufacturer’s guidelines for storage to maintain reliable blood pressure readings.
Is the MD2400 intended for single-use or reusable applications, and how does this affect its clinical or home use?
The MD2400 can be used either as a single-use or reusable device, depending on the manufacturer’s guidelines. For clinical settings, reusable models may be preferred due to cost efficiency and reduced waste, while single-use versions could be ideal for home monitoring or ambulatory care to ensure hygiene and convenience. Always verify the manufacturer’s instructions to determine the appropriate use case for your specific needs.
What regulatory pathways does the MD2400 follow, and how does this ensure its safety and performance?
The MD2400 complies with both FDA 510K and MDR (Medical Device Regulation) standards, which are designed to ensure its safety, performance, and effectiveness. The FDA 510K pathway confirms it is substantially equivalent to a legally marketed device, while MDR compliance aligns with stringent EU requirements for medical devices. These pathways collectively validate that the device meets rigorous regulatory criteria for non-invasive blood pressure monitoring.
How does the MD2400’s wrist-based design differ from traditional upper-arm blood pressure monitors, and what are its primary use cases?
Unlike traditional upper-arm monitors, the MD2400 is a wrist-based digital automatic blood pressure monitor, offering portability and ease of use for both clinical and home settings. Its wrist design makes it convenient for ambulatory care or repeated measurements throughout the day, while still providing accurate systolic and diastolic readings. It is suitable for general blood pressure assessment in environments where space or patient comfort may favor a wrist device over an upper-arm cuff.
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 | K143733 | Class II | Active |
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Manufacturer
- Manufacturer
- Grandway Technology (shenzhen) Limited
Sources (2)
- FDA 510(k) K143733 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026