There is a medical and a regulatory basis for the Loop’s sealed case. As a condition for clearing the Loop as a medical device, the FDA required that it be able to deliver its patented, therapeutic waveform consistently over its entire design life of 150 treatments. Sealing all of its operating components inside the case—the applicator connections to the circuit board, signal generator,  microprocessor, power supply and the battery—provided the FDA with the required assurance of signal integrity. Breaking the case seal for any reason renders the device non-compliant with the conditions of its 510(k) clearance.