510(k) K926314

HYDRA FITNESS MODEL 311 TOTAL POWER by Henley Intl. — Product Code ISD

K926314 is an FDA 510(k) premarket notification submitted by Henley Intl. for the device "HYDRA FITNESS MODEL 311 TOTAL POWER". The FDA issued a decision of Substantially Equivalent on March 18, 1994. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360. Henley Intl. has at least 10 other 510(k) clearances on record.