
S-Tct Health, Inc.
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EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP is an FDA 510(k)-cleared medical device (K030587) manufactured by S-Tct Health, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 29, 2003. Regulation: 8.