Blood Pressure Monitor/ Models
by Ningbo Diaier Electronic Co., Ltd.
510(k) K093739
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK093739 | Date7 May 2010 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Blood Pressure Monitor (Device Type: DXN), designed to automatically measure human systolic and diastolic blood pressure as well as heart rate. It falls under the classification of cardiovascular diagnostic devices and operates as a non-invasive tool for assessing blood pressure readings. The monitor provides features such as an average value display and irregular heart sign detection to aid in accurate assessment.
The Blood Pressure Monitor (WE100) is supplied as a reusable electronic device intended for clinical or home use. It is not sterile and requires proper calibration and maintenance as per manufacturer guidelines. The device is FDA-cleared under Special 510(k) clearance (K093739) and is manufactured by Ningbo Diaier Electronic Co., Ltd. Storage should follow the manufacturer’s instructions to ensure accuracy and longevity.
Other devices from Ningbo Diaier Electronic Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the WE100 Blood Pressure Monitor used for?
The WE100 Blood Pressure Monitor is a non-invasive cardiovascular diagnostic device designed to automatically measure human systolic and diastolic blood pressure, as well as heart rate. It includes features like an average value display and irregular heart sign detection to improve accuracy in assessing blood pressure readings. This makes it suitable for both clinical and home use environments.
Is the WE100 Blood Pressure Monitor reusable or single-use?
The WE100 Blood Pressure Monitor is a reusable electronic device. It is not intended for single-use and requires proper calibration and maintenance as outlined in the manufacturer’s guidelines to ensure continued accuracy and functionality.
How should the WE100 Blood Pressure Monitor be stored?
Storage of the WE100 Blood Pressure Monitor should follow the manufacturer’s specific instructions to maintain its accuracy and longevity. Proper storage conditions help preserve the device’s performance and prevent potential damage or calibration drift over time.
Does the WE100 Blood Pressure Monitor come with any special features?
Yes, the WE100 Blood Pressure Monitor includes an average value display, which helps provide a more stable reading by averaging multiple measurements, and irregular heart sign detection to alert users to potential anomalies in heart rhythm during the measurement process.
What regulatory clearance does the WE100 Blood Pressure Monitor hold?
The WE100 Blood Pressure Monitor holds FDA clearance under Special 510(k) clearance with the reference number K093739. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device in terms of technology and safety.