Digital Automatic Wrist Blood Pressure Monitor MD3900
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151583 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 MD3900 is a noninvasive blood pressure measurement device classified under FDA product code DXN. It measures systolic, diastolic, and mean arterial pressure using transducers applied to the wrist, providing automated readings for cardiovascular assessment.
This device is intended for single-use or reusable clinical and home monitoring settings, depending on manufacturer guidelines. Supplied sterile or non-sterile as specified, it adheres to FDA 510(k) clearance (K151583) and MDR compliance. The monitor operates in environments compatible with standard medical imaging protocols, with no noted MRI restrictions. Storage conditions follow manufacturer instructions to maintain accuracy and functionality.
Frequently asked questions
What types of environments is this blood pressure monitor suitable for, and are there any restrictions like MRI compatibility?
The MD3900 is designed for use in standard clinical and home monitoring settings. According to the provided data, it operates in environments compatible with typical medical imaging protocols and has no noted restrictions for MRI use. Always follow the manufacturer’s guidelines for optimal performance and safety.
Can this device be reused, or is it intended for single-use only?
The MD3900 is specified as suitable for *either* single-use or reusable clinical and home monitoring, depending on the manufacturer’s guidelines. Reusability would require adherence to cleaning and sterilization protocols if applicable, but the device itself does not inherently restrict reuse.
What does the FDA’s 510(k) clearance (K151583) mean for this device’s intended use?
The FDA’s 510(k) clearance under product code DXN (noninvasive blood pressure measurement) confirms the MD3900 is classified as substantially equivalent to a legally marketed predicate device for cardiovascular assessment. This means it is intended for measuring systolic, diastolic, and mean arterial pressure via wrist transducers, but the clearance does not define clinical indications—only that it meets regulatory standards for this purpose.
How should I store this monitor to ensure accuracy and functionality over time?
Storage conditions for the MD3900 must follow the manufacturer’s instructions, as specified in the data. While exact details aren’t provided, proper storage typically involves protecting the device from extreme temperatures, humidity, and physical damage to maintain calibration and performance. Always refer to the accompanying documentation for precise guidelines.
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: Digital Automatic Wrist Blood Pressure Monitor MD3900, Digital Automatic Wrist Blood Pressure Monitor MD3900 by GRANDWAY ..., Digital Automatic Wrist Blood Pressure Monitor MD3900, Digital Automatic Wrist Blood Pressure Monitor MD3900
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 | K151583 | Class II | Active |
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Manufacturer
- Manufacturer
- Grandway Technology (shenzhen) Limited
Sources (2)
- FDA 510(k) K151583 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026