AGE Automatic Upper Arm Blood Pressure Monitor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K153552 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 AGE Automatic Upper Arm Blood Pressure Monitor is an automated sphygmomanometer designed to measure and display systolic and diastolic blood pressure, as well as pulse rate in adults. It utilises an inflatable cuff wrapped around the upper arm to non-invasively assess cardiovascular parameters, providing real-time readings for clinical or home monitoring purposes.
This device is intended for single-use or reusable application in clinical or home settings, depending on manufacturer guidelines. It is not classified as MRI-safe or radiofrequency-safe, and no specific sterility standards are noted in the regulatory data. Supplied as a standalone unit, it requires proper storage to maintain accuracy and functionality. The device holds FDA 510(k) clearance under the traditional review pathway, with the clearance number K153552.
Frequently asked questions
What is the AGE Automatic Upper Arm Blood Pressure Monitor used for?
The AGE Automatic Upper Arm Blood Pressure Monitor is designed to measure and display systolic and diastolic blood pressure, as well as pulse rate in adults. It uses an inflatable cuff wrapped around the upper arm to provide non-invasive cardiovascular assessments, suitable for both clinical and home monitoring environments.
Is the AGE Automatic Upper Arm Blood Pressure Monitor single-use or reusable?
The device can be used either as a single-use or reusable unit, depending on the manufacturer’s guidelines. Proper cleaning and maintenance are required if reused to ensure accuracy and functionality.
How is the AGE Automatic Upper Arm Blood Pressure Monitor supplied?
This device is supplied as a standalone unit, meaning it does not require additional accessories beyond its core components. It is intended for standalone operation in clinical or home settings.
What storage requirements does the AGE Automatic Upper Arm Blood Pressure Monitor have?
The device must be stored properly to maintain its accuracy and functionality. While specific sterility standards are not noted in regulatory data, it is important to follow manufacturer instructions for storage to prevent damage or degradation of performance.
Is the AGE Automatic Upper Arm Blood Pressure Monitor safe for use in MRI or radiofrequency environments?
No, the AGE Automatic Upper Arm Blood Pressure Monitor is not classified as MRI-safe or radiofrequency-safe. It should not be used in environments where exposure to MRI or radiofrequency fields is present.
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: AGE Automatic Upper Arm Blood Pressure Monitor, AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR (K123882) — FDA 510(k ..., K172895 FDA 510(k) - AGE Automatic Upper Arm Blood Pressure ..., AGE Automatic Upper Arm Blood Pressure Monitor
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153552 | Class II | Active |
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Manufacturer
- Manufacturer
- Ageless Health Industrial Co., Ltd.
Sources (1)
- FDA 510(k) K153552 24 fields · synced Oct 1, 2026