510(k) K871802

MODEL K210 AND K211 FLUIDOTHERAPY UNITS by Henley Intl. — Product Code LSB

K871802 is an FDA 510(k) premarket notification submitted by Henley Intl. for the device "MODEL K210 AND K211 FLUIDOTHERAPY UNITS". The FDA issued a decision of Substantially Equivalent on September 4, 1987. The device falls under product code LSB (Unit, Fluidotherapy), a Class II device regulated under 21 CFR 890.5100. Henley Intl. has at least 10 other 510(k) clearances on record.