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Newcare Products, LLC
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MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500 is an FDA 510(k)-cleared medical device (K013167) manufactured by Newcare Products, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 29, 2002. Regulation: 8.