
Saehan Corp.
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DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 is an FDA 510(k)-cleared medical device (K052309) manufactured by Saehan Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 26, 2005. Regulation: 8.