The Max Pulse FDA approval was received in June of 2011.
It is listed as a “Photoelectric, Pneumatic or Hydralic Plethysmograph” and is listed as a Class II Device.
In order to have a 501(k) approval the device must be compared for safety and effectiveness to another device that already has approval. In this instance the Max Pulse obtained its FDA Approval based on the Meridian DPA – which we also stock and sell. Both devices use a pulse oximeter on the left index finger to track and analyze the arterial pulse wave.
The Max Pulse FDA Approval indications for use are as follows:
“The device provides noninvasive measurement of pulse waveform and heart rate by photoelectric plythysmography. The anatomical site for taking the measurment 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.