Diacore

The Diacore is a non-invasive electromagnetic muscle stimulator that applies high-intensity magnetic fields through three applicator types to induce muscle contractions. It is indicated for improving abdominal tone, strengthening abdominal muscles, and toning buttocks, thighs, calves, and arms. The device consists of a main body, color-touch LCD control screen, and applicators; it is operated by medical professionals.

Both the subject and predicate devices use magnetic fields to initiate nerve action potentials, operate via touch screen interface, and support pulse repetition rates of 1-150Hz with therapy times up to 60 minutes. The key difference is pulse width: the Diacore ranges from 175-340μs (±20%) across applicators, while the predicate ranges from 190-300μs (±20%). Both devices share identical magnetic field intensity output of 0.1-2.5T (±20%).

IEC 60601-1:2005+A2:2020, IEC 60601-1-2:2014+A1:2020, IEC 60601-2-10 (Edition 2.1), IEC 62304:2006+A1:2015, EN ISO 14971:2019, ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010. Software verification and validation testing was conducted per FDA guidance.

The Diacore is substantially equivalent because it shares the same intended use, indications, regulatory classification (Class II), and fundamental technology as the predicate device. While pulse width differs slightly (175-340μs vs. 190-300μs), the ranges substantially overlap with only minor excursions at either end. Since both devices share identical magnetic field intensity and the pulse duration difference raises no new safety concerns, substantial equivalence is established.