MOR

The MOR System is a wearable electrical stimulation device consisting of a single-use patch, reusable pulse generator, and smartphone app. It delivers user-controlled electrical stimulation to perineal muscles and nerves in adult males to improve or enhance sexual performance. The device is not intended for treating medical diseases or conditions.

The MOR patch has four electrodes with medical adhesive and conductive hydrogel, delivers stimulation at 10.5mA@140Hz or 7.5mA@200Hz, operates for a maximum of 15 minutes, and is non-sterile and single-use. It includes a reusable Li-ion battery-powered pulse generator with a push button and smartphone app control. The device is packaged as a starter kit with 6 disposable patches, charger, and accessories.

IEC 62304:2006+A1:2015 for software verification and validation; ISO 10993-1:2018 for biocompatibility; basic electrical safety and EMC testing; cytotoxicity, sensitization, and irritation testing on the patch material.

The MOR shares the same intended use as the predicate vPATCH (K223595): a non-implanted electrical stimulation device to improve sexual performance via perineal stimulation. Both devices use a patch applied to the perineum before intercourse, operate for 15 minutes, are non-sterile and single-use, and deliver short-duration electrical stimulation. The minor differences in stimulation current (10.5mA@140Hz vs. 14.3mA or 9.9mA) and packaging configuration do not raise different safety or effectiveness questions.