TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER

TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER is an FDA 510(k)-cleared medical device (K042561) manufactured by Fmd, LLC. 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 October 11, 2004. Regulation: 8.