Amplief Wrist Blood Pressure Monitor Model M600

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

510(k) Number

K050413 ↗

FDA Product Code

DXN

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Amplife Digital Infrared Ear Thermometer, Model E101

  Class II

  FDA 510(k) K042906 Active Cleared 19 Nov 2004

• Amplife Upper Arm Blood Pressure Monitor, Model M100

  Class II

  FDA 510(k) K043550 Active Cleared 27 Jan 2005

• Amplife Digital Clinical Thermometer

  Class II

  FDA 510(k) K042575 Active Cleared 30 Sep 2004

• What is the Amplief M600 wrist blood pressure monitor used for?

  The Amplief M600 is a non-invasive wrist-mounted device designed to measure blood pressure and pulse rate. It uses an electronic semiconductor sensor in an inflatable cuff to detect pressure fluctuations, converting them into electrical signals. A built-in algorithm processes these signals to provide automated readings for systolic and diastolic blood pressure, as well as pulse rate. This makes it suitable for individuals monitoring their blood pressure at home or in clinical settings where convenience and ease of use are important.

• How is the Amplief M600 supplied, and what are its usage options?

  The Amplief M600 is supplied as a standalone unit, meaning it comes ready for immediate use without additional accessories. Regarding usage, it is designed for over-the-counter use by individuals and features auto-inflation for hands-free operation. While the device is classified as either single-use or reusable (sterility status not specified in the provided data), it does not require special regulatory considerations beyond its FDA 510(k) clearance. Users should follow standard guidelines for electronic medical devices to ensure proper functionality and longevity.

• Is the Amplief M600 sterile, and how should it be stored?

  The provided data does not specify whether the Amplief M600 is sterile or not. If the device is intended for single-use, users should refer to manufacturer guidelines for proper handling and disposal. For reusable units, standard cleaning protocols for electronic medical devices should be followed. Storage conditions are not explicitly detailed, but it is recommended to adhere to general environmental guidelines for electronic medical devices, such as protecting it from extreme temperatures, moisture, and physical damage to maintain accuracy and performance.

• Does the Amplief M600 have any restrictions, such as MRI safety or special handling?

  The Amplief M600 does not have documented MRI safety restrictions, meaning it can be safely used in environments where MRI scans are performed without risk of interference or damage. However, it is always advisable to follow the manufacturer’s instructions and any additional local guidelines to ensure safe operation. Since it is an electronic device, it should be stored and handled according to standard precautions for medical electronics to avoid damage from environmental factors.

• What regulatory pathway does the Amplief M600 follow, and what does this mean for users?

  The Amplief M600 has received FDA 510(k) clearance under the reference number K050413, which means it has been deemed substantially equivalent to a legally marketed device already on the market. This clearance falls under product code DXN, classifying it as a measurement system for blood pressure, and it is categorized under FDA Class II – Special Controls. For users, this indicates that the device has undergone regulatory review to ensure its safety and effectiveness for its intended use, providing confidence in its reliability for measuring blood pressure and pulse rate.