Nais Wrist Blood Pressure Meter

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K942423 ↗

FDA Product Code

DXN

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• How does the Nais Wrist Blood Pressure Meter measure blood pressure?

  The Nais Wrist Blood Pressure Meter uses transducers placed on the wrist to detect pressure waves from the radial artery. By analyzing these waves, the device calculates systolic, diastolic, and mean arterial pressure in real time, providing accurate readings for monitoring.

• Is the Nais Wrist Blood Pressure Meter intended for single-use or reusable applications?

  The manufacturer’s specifications for single-use or reusable use are not detailed in the available data. However, the device is designed for clinical settings, including hospitals, outpatient clinics, and home monitoring, so its intended use may vary based on facility protocols and manufacturer guidelines.

• What types of environments is the Nais Wrist Blood Pressure Meter approved for?

  This device is approved for use in clinical settings such as hospitals, outpatient clinics, and home monitoring environments. Its noninvasive design and FDA clearance under the cardiovascular specialty category (DXN) make it suitable for both professional and patient self-monitoring.

• Does the Nais Wrist Blood Pressure Meter require any special storage conditions?

  The available data does not specify any special storage requirements for the Nais Wrist Blood Pressure Meter. However, standard medical device storage practices—such as protecting it from extreme temperatures, moisture, and physical damage—should be followed to maintain accuracy and functionality.

• What regulatory pathway was used for FDA clearance of this device?

  The Nais Wrist Blood Pressure Meter received FDA 510(k) clearance under the traditional review pathway, demonstrating substantial equivalence to a predicate device. The clearance was granted on February 15, 1995, and it is classified as a Class II medical device under the FDA’s product code DXN.