The Max Pulse FDA 501(k) clearance was received in June of 2011, and the number is K110374.
It is listed as a “Photoelectric, Pneumatic or Hydraulic Plethysmograph” and is listed as a Class II Device.
In order to have a 501(k) approval the device must be compared for safety to another device that already has approval. In this instance the Max Pulse obtained its FDA Approval based on the Meridian DPA. Both devices use a pulse oximeter on the left index finger to track and measure the arterial pulse wave.
The Max Pulse FDA Clearance indications for use are as follows:
“The device provides noninvasive measurement of pulse waveform and heart rate by photoelectric plethysmography. The anatomical site for taking the measurement is the left index finger. The device is intended for us with patient age 18 and older and with a weight of 100lbs or greater. The device is indicated for use in hospitals, health care clinics and physicians’ offices.”
The approval is from the division of Cardiovascular devices.