Magic InBra

The Magic InBra™ is a wearable powered breast pump designed for single-user, home-based milk expression by lactating women. It can operate on one breast with a single pump motor or on both breasts simultaneously using two pump motors. An optional smartphone app allows remote control via Bluetooth.

The subject device differs from the predicate (Pump In Style®) in several ways: it uses a liquid-filled vacuum generation system versus air-filled; it features an internal rechargeable lithium-ion battery instead of mains or AA battery power; it includes Bluetooth wireless technology and an optional mobile app, which the predicate lacks; it has a wearable design rather than portable; and it includes memory function. Both devices share the same regulatory class, indications for use, 2-phase expression mode, 10 suction levels, backflow protection, and IP22 rating.

IEC 60601-1 Edition 3.2 (electrical safety), IEC 60601-1-11 Edition 2.1 (home healthcare electrical safety), IEC 60601-1-2 Edition 4.1 (electromagnetic compatibility), ISO 10993-1 (biocompatibility), FDA guidance on device software functions and cybersecurity.

The devices share identical intended uses, regulatory classification, and fundamental operating principles. Although the subject device employs different technological characteristics—including liquid-filled vacuum generation, battery power, wireless connectivity, and a wearable form factor—these differences do not raise new safety or effectiveness questions because both devices employ the same 2-phase expression mode, deliver comparable suction ranges and cycle speeds, include equivalent user controls and backflow protection, and are both intended for home use by lactating women. Performance testing confirms the subject device meets its design specifications and maintains safety margins throughout its use life.