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Arm Blood Pressure Monitor Models: ARM-30C+ - 9S Pro

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K260276

by Shenzhen AOJ Medical Technology Co., Ltd.

Identifiers

510(k) Number
K260276 FDA 510(k)
FDA Product Code
DXN FDA 510(k)
Models / Variants
Arm Blood Pressure Monitor Models: ARM-30C+ FDA 510(k)EUDAMED
ARM-30M+ FDA 510(k)EUDAMED
ARM-HA101+ FDA 510(k)EUDAMED
ARM-3060 FDA 510(k)EUDAMED
XS Pro FDA 510(k)EUDAMED
ARM-30G1 FDA 510(k)EUDAMED
ARM-30H FDA 510(k)EUDAMED
Visomat double comfort FDA 510(k)EUDAMED
Visomat comfort 20/40 BT FDA 510(k)EUDAMED
ARM-3080 FDA 510(k)EUDAMED
ARM-3081 FDA 510(k)EUDAMED
ARM-3082 FDA 510(k)EUDAMED
ARM-3103 FDA 510(k)EUDAMED
ARM-3200 FDA 510(k)EUDAMED
ARM-115 FDA 510(k)EUDAMED
ARM-111 FDA 510(k)EUDAMED
ARM-3102 FDA 510(k)EUDAMED
ARM-3100 FDA 510(k)EUDAMED
ARM-3101 FDA 510(k)EUDAMED
SBM 15 FDA 510(k)EUDAMED
ARM-30W FDA 510(k)EUDAMED
ARM-30J FDA 510(k)EUDAMED
ARM-30F-XL FDA 510(k)EUDAMED
ARM-3024-XL FDA 510(k)EUDAMED
ARM-3025-XL FDA 510(k)EUDAMED
ARM-3062-XL FDA 510(k)EUDAMED
9S Pro FDA 510(k)EUDAMED

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 Blood Pressure Monitor is a non-invasive blood pressure measurement device designed for upper-arm cuff-based monitoring. It measures systolic and diastolic blood pressure and pulse rate, providing accurate readings for clinical and home use. The device adheres to the nomenclature for automated blood pressure monitors, ensuring compliance with regulatory standards for diagnostic accuracy.

These monitors are supplied as reusable, non-sterile devices intended for use in clinical settings, home healthcare, and ambulatory care. They are not MRI-compatible and require proper calibration and maintenance as per manufacturer guidelines. Models vary in features, including display size and connectivity options, with specific model numbers indicating distinct configurations. Authorised under FDA 510(k) clearance and MDR compliance, they are classified under product code DXN.

Frequently asked questions

Are these devices intended for single-use or reusable in clinical settings, and how should they be maintained?

These Arm Blood Pressure Monitors are designed as reusable, non-sterile devices for clinical, home, and ambulatory use. Proper maintenance is required, including regular calibration and adherence to the manufacturer’s guidelines to ensure accuracy and reliability over time.

What types of connectivity or display features differentiate the various models of this blood pressure monitor?

The models vary in features such as display size and connectivity options, though the exact specifications (e.g., Bluetooth, USB, or memory storage) are not detailed in the provided data. The model numbers (e.g., ARM-30C+, Visomat comfort 20/40 BT) may indicate distinct configurations, such as additional connectivity or ergonomic improvements.

Can these monitors be used in an MRI environment, and what safety precautions should be taken?

The Arm Blood Pressure Monitors are not MRI-compatible. If used in proximity to MRI machines, ensure the device is removed from the area to avoid interference or damage, as metallic components or electronic signals could pose risks.

How do I determine which model is best suited for my clinical or home use based on the available options?

The selection depends on specific needs like display clarity, connectivity needs, or additional features (e.g., memory storage, Bluetooth). While the data lists multiple models (e.g., ARM-30C+, Visomat double comfort), the exact functional differences (e.g., cuff size compatibility, ease of use) are not specified. Consult the manufacturer’s documentation or a healthcare professional to match your requirements.

What regulatory pathways have these devices undergone, and how does that affect their use in different regions?

These monitors are authorized under FDA 510(k) clearance and MDR compliance, indicating they meet regulatory standards for safety and performance in the U.S. and EU markets, respectively. The product code DXN (Diagnostic, Cardiovascular) reflects their classification. Always verify local regulations before use, as compliance may vary by jurisdiction.

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

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen AOJ Medical Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K260276 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced Jun 9, 2026