510(k) K131979

PROVANT THERAPY SYSTEM by Regenesis Biomedical, Inc. — Product Code ILX

K131979 is an FDA 510(k) premarket notification submitted by Regenesis Biomedical, Inc. for the device "PROVANT THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on December 13, 2013. The device falls under product code ILX (Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5290. Regenesis Biomedical, Inc. has at least 3 other 510(k) clearances on record.