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The Shape-HFTM Cardiopulmonary Testing System is a pulmonary function stationary testing system intended to be used to monitor cardiopulmonary functions during stress testing, rehabilitation, sports medicine, and other related procedures for which cardiopulmonary gas exchange measurements are medically indicated. The System provides predictive pulmonary function values that are calculated based on the data obtained during testing. The System can be used on adults and children older than 14 years old in a laboratory or clinical facility setting.

The Shape-HF™ Cardiopulmonary Testing System is a stationary device that monitors parameters during laboratory or clinical conditions. The Shape-HF™ Cardiopulmonary Testing System evaluates multiple variables of cardiorespiratory function. The System is intended to be used as a tool to aid in: 1. Cardiopulmonary health assessment; 2. Assessing heart and lung disease and defining probable sources of heart and/or lung limitations; 3. Assessing patient risk in heart and/or lung disease; 4. Assessing and monitoring physiological response to therapy, including pharmaceutical and/or medical device intervention; and 5. Assessing fitness levels and exercise tolerance.

The Shape-HF™ Cardiopulmonary Testing System is a pulmonary function stationary testing system intended to be used to monitor cardiopulmonary functions during stress testing, rehabilitation, sports medicine, and other related procedures for which cardiopulmonary gas exchange measurements are medically indicated. The System provides predictive pulmonary function values that are calculated based on the data obtained during testing. The System can be used on adults and children older than 14 years old in a laboratory or clinical facility setting.

The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions. The Shape-HF system is comparable to the Cortex Metalyzer 3BTM system (K993641). The device is software driven and electrically operated.