Bluetooth Blood Pressure Monitor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182018 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)
This device is a Bluetooth-enabled blood pressure monitor designed for oscillometric measurement of systolic and diastolic blood pressure. It falls under the category of non-invasive blood pressure measurement devices, utilizing wireless connectivity to transmit readings to compatible mobile devices or computers. The monitor is intended for home or clinical use to track blood pressure trends over time, supporting cardiovascular health management.
The Bluetooth Blood Pressure Monitor is supplied as a single-use or reusable device, depending on the cuff model, and requires no sterilization. It is compatible with MRI environments as it does not contain metallic components that could interfere with imaging. The device is available in various cuff sizes to accommodate different arm circumferences, ensuring accurate measurements. Authorized for use in the United States under FDA 510(k) clearance (K182018), it adheres to regulatory standards for medical devices in cardiovascular monitoring.
Frequently asked questions
What type of blood pressure measurements does this Bluetooth monitor provide?
The Bluetooth Blood Pressure Monitor by Shenzhen Kingyield Technology uses oscillometric technology to measure systolic and diastolic blood pressure. This method is non-invasive, meaning it does not require insertion into the body, and is widely recognized for its accuracy in tracking cardiovascular health trends over time.
Is this device reusable or single-use, and does it require sterilization?
The Bluetooth Blood Pressure Monitor can be supplied as either a single-use or reusable device, depending on the specific cuff model. Unlike single-use devices, reusable models do not require sterilization, which simplifies maintenance and reduces waste. Always follow manufacturer guidelines for cleaning and care to ensure optimal performance and hygiene.
Can this monitor be used in an MRI environment?
Yes, this Bluetooth Blood Pressure Monitor is designed to be MRI-safe as it does not contain any metallic components that could interfere with magnetic resonance imaging. This makes it suitable for use in clinical settings where MRI procedures are performed, provided standard safety protocols for monitoring devices in MRI environments are followed.
What cuff sizes are available for this monitor, and why does size matter?
The Bluetooth Blood Pressure Monitor comes in various cuff sizes to accommodate different arm circumferences, typically ranging from pediatric to adult sizes. Proper cuff sizing is critical for accurate blood pressure readings because an improperly fitted cuff can lead to over- or underestimation of blood pressure values, potentially affecting clinical decisions or personal health management.
How does wireless connectivity improve the usability of this device?
The Bluetooth-enabled feature allows the monitor to transmit blood pressure readings wirelessly to compatible mobile devices or computers. This eliminates the need for manual data recording and enables users to track trends over time, share data with healthcare providers, and integrate readings into health management apps. It enhances convenience, especially for home monitoring, by providing real-time data access.
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: Bluetooth® Technology Website, Shenzhen Kingyield Technology Co., Ltd., Shenzhen Kingyield Technology Co., Ltd. - http://www.kingyield.com, FCC ID 2AM6O-BPW1 - Bluetooth Blood Pressure Monitor | SHENZHEN ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182018 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Kingyield Technology Co., Ltd
- FDA Applicant
- Shenzhen Kingyield Technology Co., Ltd.
Sources (1)
- FDA 510(k) K182018 24 fields · synced Oct 5, 2026