Zoll Gets 510(k) Nod for Device with Military Applications The U.S. Food and Drug Administration

Zoll Gets 510(k) Nod for Device with Military Applications

The U.S. Food and Drug Administration (FDA) has given its OK to the Propaq M Monitor from Zoll Medical Corp. The device monitors vital signs and is intended for use as part of deployable military medicine and air medical operations.

Designed specifically for the tough demands of battlefield medicine (air transport and evacuation, as well as highly mobile ground, sea and air deployments of medical treatment), the Propaq M, according to the company, meets military and international standards related to durability, environmental operation and storage extremes, radio frequency emissions, and susceptibility to spurious electrical and radio frequency noise.

The development of the product—which was facilitated by grants from the U.S. Army Medical Research and Development Command—was a joint project among the U.S. Department of Defense and a cooperative agreement between Zoll and Welch Allyn Inc. (Skaneateles Falls, N.Y.). Development was facilitated with grants from the U.S. Army Medical Research and Development Command. In October 2008, Welch Allyn and Zoll entered a strategic alliance related to research and development, manufacturing, sales, service, and distribution relating to Welch Allyn’s defibrillation and monitoring products. For example, Zoll Medical distributes the Propaq line for Welch Allyn.

According to Chelmsford, Mass.-based Zoll, Propaq M is a lightweight, compact device that combines advanced capabilities with the proven features of the existing line of Propaq monitors. New features of the Propaq M include 12-lead monitoring, a third invasive pressure channel, extensive trending and data collection, a large high-contrast color display with 4-waveform capability, a night vision goggle mode for military and air medical night operations, and a user-removable battery that will operate all the physiological parameters for more than 7.5 hours. The entire package is nearly 5 lbs. lighter than currently deployed technology.

The Propaq M is a companion monitor version of the recently FDA-cleared Propaq MD transport monitor/defibrillator and has been developed to have a completely identical and common interface for operation, batteries, power supplies, blood pressure cuffs, cables, accessories and data.
Zoll Medical develops devices for defibrillation and monitoring, circulation and CPR feedback, data management, fluid resuscitation and therapeutic temperature management. The company also provides technology for clinicians and rescuers who treat victims needing resuscitation and critical care.