Delwa-Star WS-FM Blood Pressure and Body Fat Monitor

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

510(k) Number

K024077 ↗

FDA Product Code

DXN

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Zewa Mfm-007 Blood Pressure Monitor

  Class II

  FDA 510(k) K041491 Active Cleared 20 Sep 2004

• Delwa-Star Pacifier Thermometer

  Class II

  FDA 510(k) K952765 Active Cleared 13 Oct 1995

• Therma-H

  Unclassified

  FDA 510(k) K921189 Active Cleared 31 Aug 1992

• What is the Delwa-Star WS-FM Blood Pressure and Body Fat Monitor used for?

  This device is designed for non-invasive, automatic measurement of systolic and diastolic blood pressure, pulse rate, and body fat percentage. It provides quantitative data useful for assessing cardiovascular health and body composition in adults with moderately active to inactive lifestyles. The inflatable wrist cuff ensures accurate readings without requiring external connections or specialized equipment.

• How is the Delwa-Star WS-FM supplied and what are its sterility requirements?

  The monitor is supplied as a single-unit, non-sterile device intended for home use. Since it is not classified as a sterile medical instrument, standard hygiene practices—such as regular cleaning with mild soap and water—are recommended to maintain functionality and prevent contamination. No specialized regulatory sterility standards apply beyond general cleanliness.

• Is the Delwa-Star WS-FM reusable or single-use?

  The device is intended for repeated use by individual consumers in a home setting. Unlike single-use instruments, it is designed to provide ongoing measurements over time, provided it is properly maintained according to manufacturer guidelines. There are no regulatory restrictions on reuse, but users should follow basic care instructions to ensure accuracy and longevity.

• What storage conditions should be followed for this monitor?

  While specific storage instructions are not detailed in regulatory data, the device should be stored under standard environmental conditions for medical devices. This typically means keeping it in a dry, clean environment away from direct sunlight, extreme temperatures, or moisture. Avoid placing it in areas prone to physical damage or contamination, such as bathrooms or near cleaning chemicals.

• What regulatory approval does the Delwa-Star WS-FM hold?

  The device holds FDA 510(k) clearance under the product code DXN, classified as a non-invasive blood pressure measurement system. It was determined *Substantially Equivalent* (SESE) to a predicate device and authorized for commercial distribution in the U.S. The clearance was issued by the Cardiovascular (CV) Advisory Committee in 2003, following a traditional review process.