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510(k) Data Aggregation
K Number
K152115Device Name
Renew NCP-5 External Counterpulsation System
Manufacturer
Stage 2 Innovations
Date Cleared
2015-12-17
(141 days)
Product Code
DRN
Regulation Number
870.5225Why did this record match?
Applicant Name (Manufacturer) :
Stage 2 Innovations
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Renew NCP-5 External Counterpulsation System is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, increased VO2, and increased blood flow. It is intended for use under the oversight of a healthcare professional.
Device Description
The Renew"" NCP-5 External Counterpulsation System (ECS) is comprised of the following major components, a switch panel, laptop PC computer, a foldable treatment bed, main unit, and a set of patient cuffs. The device is a microprocessor-controlled system that sequentially inflates then deflates three pairs of air cuffs, which compress vascular beds in the muscles of the calves, thighs, and buttocks in synchrony with the heart cycle to achieve the desired therapy.
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