FDA Clearance


On October 31, 2007, Michigan Instruments, Inc. submitted a 510(k) notification to the FDA for the new LIFE-STAT® external cardiac compressor.  The LIFE-STAT® is an improved modification of the Thumper model 1007 mechanical CPR system, using electronic control to provide hands-free CPR compliant with the current AHA 2010 Guidelines.


In an ironic, though somehow fitting nod to the importance of matters of the heart, the FDA gave its clearance for the new LIFE-STAT® mechanical CPR system on Valentine’s Day of 2008.  The LIFE-STAT® CPR system employs computerized logic to deliver 100 chest compressions per minute with two modes of operation – 30:2 compression to ventilation (facemask mode) or continuous compressions with asynchronous ventilation (advanced airway mode).  This provides fully effective hands-free CPR, freeing rescuers for other tasks.

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