510(k) K223620

Reprieve by RegenesisTM by Regenesis Biomedical, Inc. — Product Code IMJ

K223620 is an FDA 510(k) premarket notification submitted by Regenesis Biomedical, Inc. for the device "Reprieve by RegenesisTM". The FDA issued a decision of Substantially Equivalent on May 24, 2023. The device falls under product code IMJ (Diathermy, Shortwave, For Use In 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.