
Laborie Medical Tech Corp.
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UROSTYM BIOFEEDBACK AND STIMULATION PROBES is an FDA 510(k)-cleared medical device (K990041) manufactured by Laborie Medical Tech Corp.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 4, 1999. Regulation: 8.