Arm Automatic Blood Pressure Monitor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161708 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 Arm Automatic Blood Pressure Monitor is an automatic, non-invasive oscillometric device for measuring blood pressure and pulse rate in adults. It operates by using an inflatable cuff wrapped around the upper arm to capture pressure signals, which are then converted to digital readings by the device's CPU and software.
This device is intended for home use and is supplied as a single-use or reusable product depending on the model. It is MRI safe and available in various sizes. The device has received FDA 510(k) clearance with K number K161708 and product code DXN.
Frequently asked questions
What is the Arm Automatic Blood Pressure Monitor used for?
The Arm Automatic Blood Pressure Monitor is an automatic, non-invasive oscillometric device designed for measuring blood pressure and pulse rate in adults. It operates by using an inflatable cuff wrapped around the upper arm to capture pressure signals, which are then converted to digital readings by the device's CPU and software.
Is the device single-use or reusable?
The Arm Automatic Blood Pressure Monitor is supplied as either a single-use or reusable product depending on the specific model selected. This allows for flexibility based on the user's needs and intended frequency of use.
What sizes are available for this blood pressure monitor?
The Arm Automatic Blood Pressure Monitor is available in various sizes to accommodate different arm circumferences, ensuring accurate measurements across different adult users. The specific size options should be confirmed with the manufacturer for each model.
What is the regulatory status of this device?
The Arm Automatic Blood Pressure Monitor has received FDA 510(k) clearance with K number K161708 and product code DXN. This clearance indicates that the device is substantially equivalent to legally marketed devices in the United States.
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: Shenzhen Pump Medical System Co., Ltd., Arm automatic blood pressure monitor (K151258) — FDA 510(k) | Innolitics, Shenzhen Pump Medical System Co., Ltd., ARM AUTOMATIC BLOOD PRESSURE MONITOR - Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161708 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Pump Medical System Co., Ltd.
Sources (1)
- FDA 510(k) K161708 24 fields · synced Oct 6, 2026