《ScottCare》.pdfVIP

ScottCare Corporation 800.243.9412 phone ScottCare 4791 West 150th Street 216.座机电话号码 fax Cleveland, OH 44135 web 510 K SUMMARY SPECIAL CONSIDERATION This summary of 510 k safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92 The assigned 510 k number is K/ I 3~ Date: April 18, 2008 Submitted by: ScottCare Corporation Registration No: 1527715 4791 West 15 0 th Street Cleveland, OH 44135 Contact Person: Mr. Ronald J. Clines 216-362-0550 # 113 216-264-6129 Fax rclines@ Manufacturingq Site: ScottCare Corporation Registration No: 1063268 4897 W. Waters Ave, Suite J Tampa, Florida 33634 Trade Name: ScottCare Genesis ECP Device Common Name: External Counter Pulsation ECP device Classification: 870.5225 External counter-pulsating device, Product Code: DRN Leqally Marketed Predicate Device s : Model NCP-1 Counter Pulsation Device K023016, December 12, 2002 2- 0001 Page 1 of 4 TeleRehab: Z NICORE7 Telemetry Diagnostic Cardiology External Counterpulsation ScottCare Corporation 800.243.9412 phone ScottCare 4791 West 150th Street 216.座机电话号码 fax S1-1ico~ re Cleveland, OH 44135 web Device Description: The Genesis is a non-invasive medical device for performing external, sequential counterpulsation. It is a microprocessor-controlled system that inflates and deflates three pairs of air cuffs, which compress vascular beds in the muscles of the calves, thighs, and buttocks to achieve the desired therapy. The microprocessors primary function is to serve as an R-wave detector, calculate the R-wave rate heart rate , and deliver triggering signals to actuate valves that allow the cuffs to be filled during the diastolic period and then emptied prior to systole. The secondary function of the microprocessor is to output, through a serial port,