Wrist-Type Fully Automatic Digital Blood Pressure Monitors
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K170666 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 Wrist-Type Fully Automatic Digital Blood Pressure Monitors are wrist-worn, automated devices designed to measure and display systolic and diastolic blood pressure readings. These monitors use oscillometric technology to provide accurate, non-invasive blood pressure assessments without manual inflation, making them suitable for self-monitoring in clinical and home settings.
These devices are supplied as single-use or reusable (as specified by the manufacturer) and are intended for use in environments such as hospitals, clinics, and patient homes. They comply with FDA 510(k) clearance under the Traditional pathway, classified under product code DXN, and adhere to the Medical Device Directive (MDD) and Medical Device Regulation (MDR) standards. No MRI safety information is provided, and storage conditions are not specified in the data.
Frequently asked questions
Are these wrist blood pressure monitors meant for one-time use or can they be reused?
The monitors are supplied as either single-use or reusable, depending on the specific model purchased from Joytech Healthcare. The manufacturer specifies this distinction, so you’ll need to confirm the intended use (single-use or reusable) when selecting the model that fits your clinical or home setting needs.
How do I know if this device is suitable for use in a hospital or clinic environment?
These wrist-type monitors are explicitly designed for use in clinical and home settings, including hospitals and clinics. They are FDA 510(k)-cleared under the Traditional pathway (K170666) and comply with the Medical Device Directive (MDD) and Medical Device Regulation (MDR), ensuring they meet regulatory standards for such environments.
What technology does the device use to measure blood pressure, and how does it differ from manual cuffs?
The monitors use oscillometric technology, which automatically inflates the cuff and measures blood pressure without requiring manual inflation. This makes them more convenient for self-monitoring compared to traditional manual cuffs, which require manual pumping and stethoscope listening.
Are there different sizes or models available for adults and children?
The provided data does not specify size variations (e.g., adult vs. pediatric cuffs) for these wrist-type monitors. You would need to confirm with Joytech Healthcare whether specific models accommodate different wrist sizes or age groups, as this information is not included in the regulatory submission details.
What should I consider when storing these devices, and are there any special handling instructions?
The data does not provide explicit storage conditions for these monitors. However, standard practice for electronic medical devices typically involves protecting them from extreme temperatures, moisture, and physical damage. If the devices are reusable, follow manufacturer guidelines for cleaning and maintenance to ensure accuracy and longevity.
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
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K170666 | Class II | Active |
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Manufacturer
- Manufacturer
- Joytech Healthcare Co., Ltd.
- FDA Applicant
- Joytech Healthcare Co. , Ltd.
Sources (2)
- FDA 510(k) K170666 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026